<h3>Job Description</h3>
Job Description
Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We are committed to excellence in research and invite you to be part of our dynamic team. California and the Arizona market. Known for our high standards of excellence, we are committed to providing compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team.  
Position Summary
We are seeking an experienced Clinical Research Site Manager to lead operations across multiple clinical research sites, with primary responsibility for our La Jolla, CA location. This role provides leadership to Clinical Research Coordinators at more than one site and ensures consistent, high-quality, compliant execution of clinical studies. The Site Manager will oversee staff development, operational efficiency, regulatory compliance, and data quality, while ensuring data integrity and high standards of research conduct across all assigned sites. 
This position requires travel, with occasional support at our Los Angeles clinic sites in Torrance, Long Beach, Scottsdale AZ. This role is an exempt, full-time role, working standard business hours with flexibility for early or late visits as needed for study conduct. 40 hours per week, Monday through Friday, onsite in our La Jolla Clinic.
Key Responsibilities
Multi-Site Leadership &amp; Operational Oversight:
<ul>
<li>Provide operational leadership and management across multiple clinical research sites, ensuring consistency in workflow, quality, and compliance. </li>
</ul>
<ul>
<li>Hire, onboard, train, and evaluate Clinical Research Coordinators and support staff across sites. </li>
</ul>
<ul>
<li>Monitor staffing levels and coordinate resource allocation across all active trials and locations. </li>
</ul>
<ul>
<li>Oversee day-to-day clinical operations, visit scheduling, and subject care across sites. </li>
</ul>
<ul>
<li>Ensure research staff at all locations follow protocols, SOPs, GCP, and institutional policies. </li>
</ul>
<ul>
<li>Maintain and document training standards across all assigned sites. </li>
</ul>
<ul>
<li>Contribute to patient recruitment and retention strategies across the site network. </li>
</ul>
<ul>
<li>Foster a culture of teamwork, accountability and "Quality Without Compromise" </li>
</ul>
Protocol Compliance &amp; Site Execution:
<ul>
<li>Supervise the implementation and adherence to study protocols across multiple sites. </li>
</ul>
<ul>
<li>Ensure timely and accurate source documentation and data entry at each location. </li>
</ul>
<ul>
<li>Ensure all sites meet electronic regulatory requirements and maintain audit-ready regulatory documentation. </li>
</ul>
<ul>
<li>Support internal and external audits across all assigned research sites. </li>
</ul>
Data Quality, Monitoring, &amp; Documentation:
<ul>
<li>Monitor data quality across locations to ensure accuracy, completeness, consistency, and data integrity. </li>
</ul>
<ul>
<li>Conduct remote or onsite monitoring visits at various sites to review source documents, CRFs, and regulatory materials. </li>
</ul>
<ul>
<li>Maintain data integrity and research conduct through ongoing oversight and timely resolution of data discrepancies. </li>
</ul>
<ul>
<li>Coordinate and support external monitoring visits across locations, including preparation, communication, and follow-up. </li>
</ul>
<ul>
<li>Document monitoring activities in compliance with SOPs, GCP, and ICH guidelines. </li>
</ul>
<ul>
<li>Implement and support quality assurance initiatives that enhance operational consistency and research conduct across all sites. </li>
</ul>
Regulatory, Audit, &amp; Quality Assurance Support:
<ul>
<li>Assist in audit preparation and regulatory inspections across multiple sites. </li>
</ul>
<ul>
<li>Maintain compliant regulatory files and electronic systems for each assigned location. </li>
</ul>
<ul>
<li>Identify operational or documentation gaps across sites and support corrective and preventive action plans. </li>
</ul>
<ul>
<li>
<ul>
<li>Perform additional responsibilities as needed to support multi-site clinical operations. </li>
</ul>
</li>
</ul>
Skills &amp; Qualifications
<ul>
<li>Education: Bachelor's degree in life sciences, healthcare, or related field.</li>
<li>Experience:
<ul>
<li>Minimum of 5 years of experience in clinical research, preferably involving multi-site management, monitoring, or data oversight. </li>
</ul>
<ul>
<li>Prior supervisory or team leadership experience strongly preferred. </li>
</ul>
<ul>
<li>Strong working knowledge of FDA regulations, ICH-GCP, and clinical trial operations </li>
</ul>
</li>
<li>Skills &amp; Abilities:
<ul>
<li>Strong understanding of GCP, ICH guidelines, and end-to-end clinical trial operations across multiple sites. </li>
</ul>
<ul>
<li>Excellent attention to detail and organizational skills, particularly in multi-site environments. </li>
</ul>
<ul>
<li>Strong communication skills to effectively support and coordinate cross-site teams. </li>
</ul>
<ul>
<li>Proficiency with CTMS, EDC platforms, electronic regulatory systems, and Microsoft Office Suite. </li>
</ul>
<ul>
<li>Analytical mindset with strong problem-solving capabilities. </li>
</ul>
<ul>
<li>Ability to manage priorities effectively across multiple locations. </li>
</ul>
<ul>
<li>Commitment to quality, data integrity, ethical research conduct, and regulatory compliance. </li>
</ul>
<ul>
<li>Core Values and Culture: The Clinical Research Manager is expected to embody our organization's commitment to integrity, quality, collaboration, and continuous improvement. We value leaders who promote teamwork, foster innovation, and ensure excellence in research execution. </li>
</ul>
</li>
</ul>
Compensation
The annual salary range for this position is $85k - $105k. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate's skills, education, and experience.

Physical Requirements
Ability to stand, walk, and move throughout the clinic, if applicable, for extended periods; occasionally lift objects up to 25 lbs., bend, stoop, or reach as needed. Frequent use of hands and fingers for patient care and equipment operation. Must have normal (or corrected) vision and hearing and be able to respond quickly in a fast-paced clinical environment, if applicable.
What We Offer
<ul>
<li>Competitive salary and benefits package, including medical, dental &amp; vision insurance, 401(k) retirement plan with employer matching, and professional development opportunities
<ul>
<li>In addition, we offer paid time Off (PTO), sick time, floating holiday and holiday pay </li>
</ul>
</li>
<li>Opportunity to shape the future of cutting-edge clinical research in beautiful San Diego (and across our expanding network)</li>
<li>An opportunity to play an active role in medical advancement</li>
</ul>
If this role excites you, please submit your resume and a cover letter outlining your relevant experience and why you're passionate about joining our team. We look forward to hearing from enthusiastic candidates ready to drive our success!
California Consumer Privacy Act (CCPA) Notice Orso Health ("OH") complies with the California Consumer Privacy Act ("CCPA"). Personal information provided in the job application process will be collected, used, and retained in accordance with applicable privacy laws. Candidates may request additional information regarding the categories of personal information collected and the purposes for which it is used during the hiring process.

Clinical Research Manager

<h3>Job Description</h3>
Job Description**Please note that this position requires you to be onsite at our Tinley Park, IL, USA location.
 
About Hematogenix
Want a job with greater meaning and higher purpose? Every day Hematogenix employees are warriors fighting a noble and global war on cancer. Helping patients every day, and helping partners every day – with our diagnostic and research services. 
Hematogenix is looking for talented and highly motivated individuals to join our team. We offer a competitive benefit package and career development opportunities to help you achieve your highest professional and personal goals. We are eager to show you all we have to offer and how you can grow with us.
Hematogenix is a specialized contract research organization and clinical laboratory with a global presence. Our team of board-certified clinical, anatomic and research pathologists work in conjunction with top scientists from around the world to provide quality testing, consultation, and guidance for all aspects of the company’s pharma and diagnostic services. 
 
Job Purpose:
The Project Manager is responsible for successful planning of global phase II/III registrational clinical trials, study start up activities, logistics set up and support, study sample and data query management, monitoring turnaround times, data reconciliation and close out activities. Includes but not limited to: 
<ul>
<li>manage the scope of clinical trial projects, ensuring objectives, timelines, quality standards, and budgets constraints are fully met. </li>
<li>anticipate and respond to any challenges that may occur during the lifecycle of a project. </li>
<li>deliver excellent customer service to clients and other project stakeholders. </li>
<li>reports to Hematogenix Executive Team </li>
</ul>
 Accountabilities/Work Activities:
Study Initiation
<ul>
<li>Participate in meetings with potential clients to fully understand a project’s objectives and timelines.</li>
</ul>
Planning &amp; Design
<ul>
<li>Identify required activities of projects.</li>
<li>Contribute to the creation of a mutually agreed upon Scope of Work documents with Sponsors.</li>
<li>Liaison with Hematogenix SMEs to support complex biomarker projects</li>
<li>Create study specific Laboratory Manuals and maintain required regulatory documents.</li>
</ul>
Executing
<ul>
<li>Host in-house or remote initiation meetings with all project personnel to ensure participants understand their individual contributions, as well as overall study objectives and timelines.</li>
<li>Develop and train project team as clinical trial projects formally begin </li>
<li>Create and maintain study tracking documents to ensure timelines are adhered to as applicable to each specific study or Sponsor requirements.</li>
</ul>
Monitoring &amp; Controlling
<ul>
<li>Continually monitor progress of projects </li>
<li>Ensure project supplies and resources are being adequately maintained.</li>
</ul>
Study Closing
<ul>
<li>Support all Close out activities depending on the scope of services as applicable to the study design or Sponsor’s requirements. </li>
<li>Participate in any Close Out Visits</li>
<li>Support study audits as needed.</li>
</ul>
 Experience and Education
<ul>
<li>Minimum Bachelor of Science degree with experience in Clinical Laboratory Science</li>
<li>2-3 years’ experience in Project Management supporting Phase II/III global clinical trials.</li>
</ul>
 Skills and Qualifications
<ul>
<li>Knowledge of GCP/CAP/CLIA and clinical project management processes</li>
<li>Knowledge of global clinical research industry and associated regulations</li>
<li>Must be able to communicate effectively and persuasively, both verbally and in writing, with clients, all levels of in-house Hematogenix personnel, and other project stakeholders</li>
<li>Personal computer skills (Microsoft Word, Excel, Power Point, etc.)</li>
<li>Ability to ambulate throughout the office and laboratory.</li>
</ul>
Benefits we Offer:
<ul>
<li>Medical</li>
<li>Dental </li>
<li>Vison </li>
<li>Life</li>
<li>401k </li>
<li>PTO</li>
<li>Competitive Salary </li>
</ul>
Contact Information:
<a href="mailto:jobs@hematogenix.com" target="_blank">jobs@hematogenix.com</a>; <a href="http://www.hematogenix.com" target="_blank">www.hematogenix.com</a>

Hematogenix provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Clinical Project Manager

<h3>Job Description</h3>
Job DescriptionCompany Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at&nbsp;<a href="http://www.abbvie.com" target="_blank">www.abbvie.com</a>. Follow @abbvie on&nbsp;X,&nbsp;Facebook,&nbsp;Instagram,&nbsp;YouTube,&nbsp;LinkedIn&nbsp;and&nbsp;Tik Tok.
Job Description 
AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program and maintaining best in industry resources.
This role is on our Study Data Tabulation Model focused team.
 Responsibilities:&nbsp;
<ul>
<li>Manage multiple TAs</li>
<li>Manage technology evaluations and implementations for performance improvement and cost reduction.</li>
<li>Creates and sustains an environment that attracts, develops and retains strong talent.</li>
<li>Practice continuous improvement of processes and technology usage.</li>
<li>Acts as subject matter expert and process owner.</li>
<li>Supervises and allocates internal and external resources within the Therapeutic Area.</li>
<li>Ensure all performance assessment responsibilities are achieved for direct reports. Provide training and feedback, resolve personnel issues, and manage talent retention for assigned staff.</li>
<li>Responsible for the performance management of staff; supporting team in building and maintaining a high performing team, recruitment, onboarding, resource assignment, and development opportunities for staff within responsibility.</li>
<li>Manage cross functional initiatives.</li>
<li>Provides strategic direction, advice and guidance to staff in relation to operations responsibilities and activities; promotes best practice; ensures objectives are successfully met.</li>
</ul>
&nbsp;
Qualifications 
Minimum Qualifications:
&nbsp;
<ul>
<li>Bachelor’s degree in management information systems, computer science, life sciences or equivalent.</li>
<li>Must have 8+ years of experience with clinical database design, data loading, and database modeling concepts or 9+ years of experience in a similar technical or clinical development environment.</li>
<li>Experience performing Quality Control (QC) of SDTM datasets to ensure accuracy, completeness, and conformance to P21 before it is released to the&nbsp;Data Standards and Stat Programming team</li>
<li>Experience Training DWA programmers on SDTM concepts</li>
<li>Experience leading or participating in process improvement initiatives aimed at increasing QC efficiency and SDTM programming quality.</li>
<li>Demonstrated intermediate SAS and/or SQL programming skills and expert knowledge of database concepts.</li>
<li>In-depth knowledge of CDASH and SDTM Standards In-depth understanding of clinical trial processes</li>
</ul>
Preferred Qualifications:
<ul>
<li>Master’s preferred.</li>
</ul>
Other Required Skills:
<ul>
<li>Demonstrated ability to influence others without direct authority. Demonstrated performance as a key contributor to initiatives and advancement of the organization. Demonstrated ability to successfully coach/mentor in a matrix environment Demonstrated effective communication skills Demonstrated effective analytical skills</li>
</ul>
 Additional Information 
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&nbsp;local law:&nbsp;​
<ul>
<li>
The compensation range described below is the range of possible base pay compensation that the Company&nbsp;believes in&nbsp;good faith it will pay for this role at the time&nbsp;of this posting based on the job grade for this position.&nbsp;Individual&nbsp;compensation paid within this range will depend on many factors including geographic location, and&nbsp;we&nbsp;may ultimately&nbsp;pay more or less than the posted range. This range may be modified in the&nbsp;future. ​
</li>
<li>
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&nbsp;medical/dental/vision&nbsp;insurance and 401(k) to eligible&nbsp;employees.​
</li>
<li>
This job is eligible to participate in our short-term incentive&nbsp;programs.&nbsp;​
</li>
<li>
This job is eligible to participate in our long-term incentive&nbsp;programs​
</li>
</ul>
​
Note: No amount of pay&nbsp;is considered to be&nbsp;wages or compensation until such amount is earned, vested, and&nbsp;determinable.&nbsp;The amount and availability of any bonus,&nbsp;commission, incentive, benefits, or any other form of&nbsp;compensation and benefits&nbsp;that are allocable to a particular employee remains in the Company's sole and&nbsp;absolute&nbsp;discretion unless and until paid and&nbsp;may be modified at the Company’s sole and absolute discretion, consistent with&nbsp;applicable law.&nbsp;
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.&nbsp;
US &amp; Puerto Rico only - to learn more, visit&nbsp;<a href="https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html" target="_blank">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.ht…</a>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
<a href="https://www.abbvie.com/join-us/reasonable-accommodations.html" target="_blank">https://www.abbvie.com/join-us/reasonable-accommodations.html</a>

Senior Manager Clinical Data Systems - SDTM (Remote)

<h3>Job Description</h3>
Job DescriptionDescription:
The Temporary Clinical Study Manager is responsible for the successful execution of clinical trials from protocol conception through to clinical study report. The Temporary Clinical Study Manager ensures completion of study deliverables and proactively identifies and resolves clinical project issues. This role is accountable for leading the extended clinical study team and supporting the strategic planning and execution of clinical trials ensuring compliance with regulatory and legal requirements, ensuring high quality execution, clinical trial participant safety and data integrity.
 
This role can be based remote with monthly travel to Norwood, Ma.
 
Primary Responsibilities:
<ul>
<li>Clinical operations leader who drives the successful execution of all operational components of a study, using strong project management, leadership and organizational skills. </li>
<li>Develop comprehensive study timelines and metrics</li>
<li>Develop and manage study budget within financial goals</li>
<li>Management of risk associated with KPI and issue escalation</li>
<li>Prepare and present project briefings, as required; plan, execute, and lead or participate in study-specific meetings</li>
<li>Coordinates and participates in periodic data quality review and may contribute to interpretation of clinical trial results</li>
<li>Coordinates with Data Management, Statistics, Medical and other functions for full life cycle management of clinical trial activities</li>
<li>Identify and assist in selection of external vendors required and the development of vendor specifications. Review and prepare vendor reports related to vendor proposals with recommendations</li>
<li>Assist in the selection and evaluation of study personnel (contract and internal)</li>
<li>Provide or facilitate study-specific training to clinical research staff, and other contract personnel</li>
<li>Manage study-related vendors and serve as the primary point of contact for all contracted vendors (CROs, SMOs, Labs, Meeting Planner, etc)</li>
<li>Identify potential risks and resolve issues with CROs while establishing vendor management plans and reviewing quality metrics</li>
<li>Participate in site and country selection. Review completed feasibility questionnaires to assist with site selection. Develop relationships with investigators and site staff</li>
<li>Prepare and review site study documents: site-specific informed consent, study tools/worksheets, investigator contracts and site payments</li>
<li>Oversee clinical monitoring activities, ensuring compliance with (GCP) and applicable regulations</li>
<li>Participate in site co-monitoring visits as appropriate</li>
<li>Support the design of clinical trial protocols along with the study team and consistent with the clinical development plan</li>
<li>In collaboration with the Clinical Scientist, develop ongoing data review plan to ensure data trend detection and study objectives are met</li>
<li>Prepare study-related documentation; provide input for the design of ICF template, CRFs, monitoring conventions, edit checks, etc.</li>
<li>Prepare and/or review study-related documents including the Site Performance Plan, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and Risk Mitigation Plan</li>
<li>Provide input and support documentation for adverse event safety monitoring while collaborating on FDA and regulatory authorities report submissions</li>
<li>Coordinate with CMC or Clinical Supply to facilitate study drug manufacture, packaging, labeling and distribution</li>
<li>Participate in planning of QA activities and coordinate resolution of audit findings</li>
<li>Ensure audit-ready clinical trial documentation including central clinical files. Review monitoring reports, ensuring quality and resolution of site-related issues</li>
<li>Coordinate and assist regulatory or ethics committee activities planning</li>
<li>Provide oversight to maintain clinical trial master files and ensure appropriate compliance and completeness</li>
<li>For any study CAPA raised perform a root cause analysis, as well as drive all actions to completion, within the expected timeframe</li>
<li>Lead and consistently be present for the Cross-Functional Study Team as well as for internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.)</li>
<li>May represent Clinical Operations in other cross-functional activities or participate in functional initiatives in support of departmental objectives</li>
<li>This role reports directly to the Senior Director, Clinical Operations.</li>
</ul>
 
Requirements:
 
<ul>
<li>Bachelor’s Degree (health, biologic science or related field) required</li>
<li>Minimum of 8 years clinical study management experience in biopharmaceutical industry, including at least 5 years as a clinical study lead/project manager, required</li>
<li>Prior experience managing contracted resources/CRO required</li>
<li>Experience managing metabolic clinical programs through phase 1-4, experience with oncology is preferred</li>
<li>Site monitoring and clinical data review experience highly preferred</li>
<li>Clinical quality compliance experience highly preferred</li>
<li>Advanced knowledge of GCP and current knowledge of US, EU and UK regulations</li>
<li>Knowledge of ICH and other country regulatory requirements is preferred</li>
<li>Excellent communication, organizational, problem-solving, conflict resolution, leadership and team-building skills required</li>
</ul>
Corbus Culture:
Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our “family” atmosphere where each person’s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.
 
About Corbus:
Corbus is an oncology and obesity company committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ internal development pipeline includes CRB-701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin 4-on cancer cells to release a cytotoxic payload and CRB-601, and anti-integrin monoclonal antibody which blocks the activation of TGFß expressed on cancer cells. Additionally, we are developing a cannabinoid receptor-1 (CB-1) inverse agonist as potential treatment for obesity. Corbus is headquarters in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

Temporary Clinical Study Manager

<h3>Job Description</h3>
Job DescriptionSalary: Starting at $85,000 Annually 
Why DelRicht Research?
Would you love to be a part of the cutting edge of healthcare and science innovation? Do you want to be an influential part of a rapidly growing team? Are you looking for a position that has opportunities for professional growth? If the answer is yes, then DelRicht Research might be the right opportunity for you! 
Who We Are
DelRicht is a clinical research company dedicated to providing an excellent customer experience to all patients that participate in our clinical trials. Our clinical trials provide new treatment options for our patients and ultimately our goal is to get new medications and medical devices FDA approved! We hold our team members to a high standard of excellence and are looking for energetic, positive, quick learners to be a part of our team. Presently our network stretches across 33 sites throughout the United States in 18 states.
 
DelRicht Research has been recognized as a Top Workplace in 2023, 2024, and 2025! This is a testament to our unwavering commitment to creating an exceptional work environment that fosters growth, collaboration, and employee satisfaction.
 
Clinical Research Site Manager's Main Objective: In this role you will be responsible for the day to day management of clinic operations, including financial oversight and people management.
 
The Clinical Research Site Manager will maintain all activities related to the conduct of clinical trials at the site including but not limited to:
<ul>
<li>Lead by example in delivering warm, excellent care to every patient at every visit.</li>
<li>Ensure patient visits are conducted with 100% protocol adherenceaccurately, efficiently, and on time.</li>
<li>Oversee a team of physicians and other team members conducting the sites clinical trials</li>
<li>Manage a team of Clinical Research Coordinators for their growth and development within the role and company which will also include managing the schedule, conducting performance reviews, overseeing individual and group productivity and quality of work</li>
<li>Continue to build the team by hiring and training as needed with the growing region</li>
<li>Seeing to it that all clinical trial protocols are being adhered to 100% of the time</li>
</ul>
<ul>
<li>Manage physician relationships and ensure they are aware of their schedules and informed about all clinical trial patients</li>
</ul>
<ul>
<li>Problem solve with the physicians and coordinators to resolve any patient-related issues that may arise</li>
</ul>
<ul>
<li>Communicate effectively with external clients regarding site visits as well as the sites quality and quantity of data for all trials</li>
</ul>
<ul>
<li>Ensure the site is maximizing the schedule in order to provide opportunities to as much of the community as possible</li>
</ul>
<ul>
<li>Responsible for the region reaching profitability and revenue goals</li>
</ul>
<ul>
<li>Learn and prepare for new clinical research studies at the site (typically 1-2 new clinical studies per month)</li>
</ul>
<ul>
<li>Voluntary travel to Investigator Meetings to learn about new clinical studies (US based, all expenses paid - who doesnt like free travel?) </li>
</ul>
The Right Candidate Will:
<ul>
<li>Be self motivated! Energetic! Positive!</li>
</ul>
<ul>
<li>Focus on providing exceptional patient care and creating memorable experiences</li>
</ul>
<ul>
<li>Make sure client satisfaction is a primary focus and that the client is able to achieve and exceed their goals</li>
</ul>
<ul>
<li>Believe in high quality and have a high standard of compliance to our study protocols</li>
</ul>
<ul>
<li>Be remarkably organized</li>
</ul>
<ul>
<li>Be skilled at problem solving, planning and being proactive</li>
<li>Accept ownership of tasks from inception through completion and assume responsibility for personal success</li>
</ul>
 
Skills needed to win:
 
<ul>
<li>Required: 1 year of supervisory or managerial experience, ideally in a Healthcare or Healthcare related occupation</li>
<li>Required: 3-4 years of professional clinical experience in a patient facing role</li>
<li>Required: The ability to help drive teams while also routinely contributing to patient visits</li>
<li>Required:B.S or B.A from any accredited University</li>
<li>Strong communication and decision-making skills </li>
<li>Be self motivated! Energetic! Positive!</li>
<li>Enjoy a fast-paced working environment</li>
<li>Believe in high quality and have a high standard of compliance to our study protocols</li>
<li>Be remarkably organized</li>
<li>Accept ownership of tasks from inception through completion and assume responsibility for personal success</li>
<li>This is an onsite Monday-Friday position. No remote or hybrid seeking applicants please</li>
<li>Coffee drinkers preferred. Tea drinkers accepted.</li>
</ul>
 
 
The Company Culture You Will Be Part Of: DelRicht Researchs Core Values: Production, Humility, Consistency
Production:
<ul>
<li>We deliver on our promises</li>
</ul>
<ul>
<li>We have a bias towards action: we value independent problem solving</li>
</ul>
<ul>
<li>We proactively over deliver: we can act without being told what to do and we always have new ideas that will be heard and will improve the company</li>
</ul>
Humility:
<ul>
<li>We support each other relentlessly</li>
</ul>
<ul>
<li>We always have enthusiasm: we exhibit passion and excitement about our work which leads to everyone having a can do attitude</li>
</ul>
<ul>
<li>We embrace change: we are excited to always be growing and moving the organization forward which means change is the norm for us</li>
</ul>
<ul>
<li>Coachable: we all love to learn, we are willing to be taught and will adapt quickly</li>
</ul>
Consistency:
<ul>
<li>We always are able to execute: we get it right the first time and promote touch it once accuracy</li>
</ul>
<ul>
<li>We have persistence: we demonstrate the tenacity and willingness to go the distance to get something done</li>
</ul>
<ul>
<li>We are calm under pressure: we can maintain stable performance when under heavy pressure or stress</li>
</ul>
Our team comes first so here are some of the perks and benefits at DelRicht Research:
<ul>
<li>Medical, Dental and Vision Insurance</li>
<li>Short Term Disability, Long Term Disability, and Life Insurance</li>
<li>Generous Paid Time Off that builds throughout your career with the company</li>
</ul>
<ul>
<li>Even though we are in healthcare, we do not work nights, weekends or 12 hour shifts (yes, nurses love us!)</li>
<li>401K (includes discretionary match/profit sharing)</li>
<li>Exceptional quarterly bonus plan that clearly outlines your bonus potential per quarter and gives managers the visibility and control to maximize earnings by hitting team goals</li>
</ul>
 
Job Type: Full-time 40+ hrs
Visit our website linked below to learn about our company and current clinical trials, see patient testimonials, and check out our careers page! 
<ul>
<li>Website: <a href="http://www.delrichtresearch.com" target="_blank">www.delrichtresearch.com</a></li>
<li>Patient Testimonials: <a href="https://delrichtresearch.com/testimonials/" target="_blank">https://delrichtresearch.com/testimonials/</a></li>
<li>Meet some of the team: <a href="https://delrichtresearch.com/careers/" target="_blank">https://delrichtresearch.com/careers/</a></li>
</ul>
 We are an equal opportunity employer and consider all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Clinical Research Site Manager

<h3>Job Description</h3>
Job Description
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit <a href="http://www.CareAccess.com" target="_blank">www.CareAccess.com</a>.
How This Role Makes a Difference
Care Access Research is currently looking to hire a full time, remote, Clinical Vendor Activation Manager. The Clinical Vendor Activation Manager serves as a dedicated resource within the Study Start Up Department (SSU) to oversee vendor engagement during clinical trial start-up and execution. This role ensures vendors are qualified, contracted, and aligned with study protocols and activation timelines. The Clinical Vendor Activation Manager combines operational vendor oversight with clinical insight, enabling Care Access to activate studies on time and support the site network effectively. 
How You'll Make An Impact
Clinical protocol review and vendor needs identification
<ul>
<li>Review clinical protocols and study documents to determine vendor scope and compatibility; translate protocol elements into vendor qualifications and expectations.</li>
</ul>
Clinical consultation for vendor qualification
<ul>
<li>Provide clinical insight to the Vendor Management and SSU teams to support vendor selection, feasibility, and site alignment. </li>
</ul>
<ul>
<li>Collaborate with SSU, Regulatory, Site Ops, Legal, Vendor Management, and other departments to align on vendor strategy, timelines, and documentation flow.</li>
</ul>
Vendor onboarding and issue escalation
<ul>
<li>Guide vendors through training expectations based on protocol requirements; assist internal teams in clarifying procedural expectations and documentation needs. </li>
</ul>
<ul>
<li>Identify and troubleshoot vendor-related issues impacting clinical execution or study timelines; act as clinical escalation point for vendor readiness concerns.</li>
</ul>
Clinical support during SEV and site activation 
<ul>
<li>Participate in SEV preparation and vendor-related activation readiness, ensuring clinical requirements are addressed early in the start-up process, with an 'outside-the-box' mindset to identify creative solutions with sites and managers to meet deliverables </li>
</ul>
Other Responsibilities
<ul>
<li>Serve as the clinical point-of-contact for vendors, ensuring timely responses when study manuals are unavailable.</li>
<li>Standardize and improve communication pathways between vendors, SSU teams, and internal stakeholders.</li>
<li>Monitor vendor performance, proactively raise risks based on historical knowledge, and escalate concerns impacting KPIs.</li>
<li>Document and track contracting and qualification timelines, escalation history, and vendor performance metrics in internal systems</li>
<li>Support relationship-building with vendors, sponsors, site networks, and investigators by ensuring consistent, high-quality messaging.</li>
<li>Develop and refine vendor management processes to optimize efficiency and quality.</li>
<li>Contribute to pipeline planning by maintaining accurate vendor historical records and lessons learned.</li>
<li>Apply data management skills to track KPIs and ensure compliance with site network requirements.</li>
<li>Negotiate with vendors and sponsors, demonstrating sales ability when communicating the benefits of partnering with Care Access.</li>
<li>Maintain vendor documentation, records of communications, and escalation logs.</li>
<li>Represent Vendor Management in clinical and operational discussions with sponsors, CROs, and vendor teams.</li>
<li>Guide internal and external stakeholders on vendor requirements, protocol expectations, training, and procedures.</li>
<li>Participate in governance calls and internal meetings to provide updates on vendor performance and risk status.</li>
<li>Develop tools, templates, and training materials to strengthen vendor onboarding and oversight processes.</li>
<li>Oversee vendor relationships, ensuring compliance with company policies, service level agreements, and performance standards.</li>
<li>Review, negotiate, and manage contracts throughout their lifecycle, including renewals and amendments.</li>
<li>Monitor vendor performance, resolve escalations, and recommend improvements to optimize cost, quality, and service.</li>
</ul>
The Expertise Required
<ul>
<li>Strong understanding of clinical protocols, trial execution, and start-up workflows. </li>
<li>Prior vendor experience with the ability to discuss protocol clinical aspects with vendors. </li>
<li>Skilled at guiding vendor partners and internal teams on protocol expectations, training, and procedures. </li>
<li>Effective communicator of vendor requirements both internally and externally. </li>
<li>Experience interacting with sponsors and their preferred vendor teams to review expectations and qualifications. </li>
<li>Experience working with site networks; direct site-based experience strongly valued. </li>
<li>Ability to negotiate and 'sell' Care Access's value to vendor partners and sponsors. </li>
<li>Experience interacting with investigators, clinical staff, and site teams to support operational decision-making. </li>
<li>Strong cross-functional communication skills in a fast-paced, matrixed environment. </li>
<li>Creative, outside-the-box problem solving with openness to brainstorming solutions. </li>
<li>Proactive mindset with ownership, accountability, and focus on clinical quality. </li>
<li>Ability to foresee risks based on historical knowledge, manage escalations efficiently, and follow up across governance structures. </li>
<li>Data management skills for tracking KPIs, vendor performance, and escalation logs. </li>
<li>Ability to hold vendors accountable to agreed timelines and deliverables. </li>
<li>Capacity to effectively document historical vendor performance and leverage it for future pipeline planning. </li>
<li>Experience creating and implementing new processes based on role and company needs. </li>
<li>Experience reviewing, interpreting, and providing feedback on vendor contracts, including identifying risks, obligations, and compliance requirements. </li>
<li>Proven ability to manage the full lifecycle of vendor contracts, from negotiation through execution, renewal, and termination. </li>
</ul>

Certifications/Licenses, Education, and Experience:
<ul>
<li>Bachelor's degree in life sciences, healthcare, nursing, or related field (advanced degree preferred). </li>
<li>3–5 years of experience in clinical operations, vendor management, or clinical trial start-up. </li>
<li>Prior vendor-facing experience within clinical trials required. </li>
<li>Familiarity with vendor qualification systems, contracting workflows, and site activation processes. </li>
<li>Experience in SSU, Clinical Project Management, or Vendor Oversight strongly preferred. </li>
<li>Proficiency with CTMS, clinical portals, and project tracking tools. </li>
</ul>
How We Work Together
<ul>
<li>Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.</li>
<li>Travel: This is a remote position with less than 20% travel requirements. Occasional planned travel may be required as part of the role.</li>
<li>Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.</li>
</ul>
Benefits &amp; Perks
<ul>
<li>Paid Time Off (PTO) and Company Paid Holidays</li>
<li>100% Employer paid medical, dental, and vision insurance plan options</li>
<li>Health Savings Account and Flexible Spending Accounts</li>
<li>Bi-weekly HSA employer contribution</li>
<li>Company paid Short-Term Disability and Long-Term Disability</li>
<li>401(k) Retirement Plan, with Company Match </li>
</ul>
Diversity &amp; Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. 
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: <a href="mailto:TalentAcquisition@careaccess.com" target="_blank">TalentAcquisition@careaccess.com</a>

Clinical Vendor Activation Manager

<h3>Job Description</h3>
Job DescriptionWHOOP is an advanced health and fitness wearable, on a mission to unlock human performance and healthspan. WHOOP empowers its members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Project Manager, Clinical Trials, you will play a key role in supporting the execution of WHOOP-sponsored clinical studies. You will manage day-to-day project operations, including study timelines, budgets, regulatory submissions, and cross-functional coordination. Your role will ensure studies are executed with compliance, quality, and operational excellence while contributing to WHOOP’s mission to validate digital biomarkers and support regulatory pathways for novel health applications. You will collaborate closely with internal stakeholders, external partners, and study sites to ensure smooth study startup, monitoring, and close-out. Your expertise in project management will enable you to track deliverables, identify risks, and support the development of critical study documentation and SOPs.RESPONSIBILITIES:
<ul>
<li>Oversee timelines, budgets, milestones, and deliverables for multiple WHOOP-sponsored studies; provide regular updates to leadership and external stakeholders.</li>
<li>Lead daily or bi-weekly standups with cross-functional teams and manage task delegation and workload distribution across internal team members and vendors.</li>
<li>Support study design, startup, monitoring, and close-out, including IRB submissions, Kick Off Meetings, documentation deliverables, and status tracking.</li>
<li>Support the preparation, review, and approval of study protocols, informed consent forms, study plans, and other key documents.</li>
<li>Collaborate with CROs, academic partners, and research sites to ensure smooth execution and high-quality data capture.</li>
<li>Ensure adherence to GCP, ICH, FDA, and other applicable requirements; draft and finalize project management SOPs and templates for clinical trials.</li>
<li>Identify project risks, propose mitigation strategies, and maintain proactive communication with stakeholders.</li>
<li>Gather agenda items, lead meetings, and oversee meeting notes and follow-up actions across the Digital Health team.</li>
</ul>
QUALIFICATIONS:
<ul>
<li>Bachelor’s degree in Life Sciences, Public Health, Nursing, or related field.</li>
<li>2–3 years of experience in clinical research project management, preferably in medical devices, software as a medical device, or digital health.</li>
<li>Ability to manage and track 2–3 projects simultaneously.</li>
<li>Strong knowledge of GCP, ICH, FDA, and related regulatory guidelines including ISO 14155.</li>
<li>Excellent organizational, problem-solving, and communication skills with the ability to manage multiple stakeholders across technical and scientific domains.</li>
<li>Proficiency with project management tools such as Jira, Confluence, Google Sheets, and Box.</li>
<li>Passion for health, wellness, and WHOOP’s mission.</li>
<li>Experience with wearable devices, digital biomarkers, or remote clinical trial designs preferred.</li>
<li>Familiarity with data-driven health technologies or regulated medical devices preferred. </li>
<li>PMP or equivalent project management certification (preferred but not required).</li>
</ul>
This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.&nbsp; Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in&nbsp;E-verify&nbsp;to determine employment eligibility.&nbsp; It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success. The U.S. base salary range for this full-time position is $75,000 - $110,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.&nbsp; In addition to the base salary, the successful candidate will also receive benefits and a generous equity package..&nbsp; These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements. Learn more about WHOOP.

Project Manager (Clinical Trials)

<h3>Job Description</h3>
Job Description
Our client is seeking a Senior Clinical Project Manager / Associate Director, Clinical Operations to lead the clinical operations for their early-phase celiac disease trial. This role offers the opportunity to manage a CRO team, oversee study timelines and budgets, and contribute to protocol design and trial strategy. The position is remote-friendly, reports to the CMO, and provides a clear path to grow into a Director of Clinical Operations as the company’s pipeline expands post-merger. Ideal candidates have experience leading teams at CROs, managing early-phase studies, and driving complex clinical programs to deliver results.
 
Main purpose of the job:
To assist with the clinical activities to support our clients’ portfolio of research and development projects. All activities carried out with regard to time, cost, and quality, and in accordance with SOPs, ICH/ GCP guidelines, and local regulations.
 
Key responsibilities include:
<ul>
<li>Management and oversight of all aspects of allocated studies in accordance with internal SOPs, ICH GCP, relevant guidelines, and all applicable laws and regulations.</li>
<li>Study team coordination and leadership.</li>
<li>Oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality.</li>
<li>Responsibility for the preparation of study documentation and coordination of document review, e.g., protocols, IBs, DSURs, ICFs, CSRs.</li>
<li>Selection and oversight of assigned CROs, vendors, or contract monitors (CRAs), as appropriate.</li>
<li>Selection of suitable clinical sites in collaboration with other members of the Barinthus study team or CROs, as appropriate.</li>
<li>Periodic co-­‐monitoring with contract CRAs or CROs as necessary for each study, to ensure high-quality monitoring and site management.</li>
<li>Set up and management of clinical contracts (including Clinical Site Agreements).</li>
<li>Coordination of IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Head (or CRO if delegated) for regulatory submissions.</li>
<li>Preparation of study budgets, forecasting, and accruals.</li>
<li>Thorough documentation of study team activities, decisions, actions, and risk assessments.</li>
<li>Active management of clinical trials supply requirements in collaboration with 3rd party storage &amp; distribution specialists.</li>
<li>Oversight of Sponsor Oversight File and/or TMF creation and maintenance by Clinical Trial Administrator, to ensure ‘inspection-­‐ readiness’ of documentation at all times.</li>
<li>Active acquisition and furthering of therapeutic area knowledge appropriate to assigned studies.</li>
<li>Assist with departmental development work, e.g., SOP review/writing and process improvements initiatives.</li>
<li>Develop and maintain relations with sites and KOLs.</li>
</ul>
 
Other Responsibilities of the Role:
Personal abilities and traits:
<ul>
<li>Demonstrates personal drive and goal orientation.</li>
<li>Self-motivated, taking personal pride in delivering on personal and corporate objectives.</li>
<li>Enthusiastic and flexible to change.</li>
<li>Demonstrates strong organisational and prioritisation skills to manage a diverse workload.</li>
<li>Able to interact with individuals at all levels of the organisation.</li>
<li>A highly effective communicator, both orally and in writing, with an eye for detail/ accuracy.</li>
<li>Reliable and trustworthy, able to work with minimal supervision.</li>
</ul>
 
Qualifications and/or experience required to perform the role
Essential knowledge, experience, and skills:
<ul>
<li>BSc or equivalent.</li>
<li>Clinical study management experience within a pharmaceutical, biotech, or CRO company.</li>
<li>Experience in oversight of external vendors (CROs, central labs, imaging vendors, etc).</li>
<li>Excellent written and verbal communication and presentation skills.</li>
<li>Excellent organisational and interpersonal skills.</li>
<li>Ability to manage multiple priorities within one or across different projects.</li>
<li>Excellent working knowledge of GCP and current clinical trial legislation.</li>
<li>Thorough knowledge of the clinical development process, ideally from first-in-human through to regulatory filing for marketing.</li>
<li>Ability to travel in the USA and abroad periodically if needed.</li>
<li>Ability to work in a dynamic small team environment.</li>
</ul>
 
Desired skills:
<ul>
<li>Experience in early phase (I-­‐II) studies.</li>
<li>Working with GMO experience.</li>
<li>CRA/monitoring experience.</li>
<li>Experience of EDC and eTMF; comfortable with electronic systems, e.g., CTMS.</li>
<li>Autoimmune Diseases and Immunology experience.</li>
</ul>

Sr. Clinical Project Manager / Associate Director, Clinical Operations

<h3>Job Description</h3>
Job Description
Customer Success Manager – Remote (Full-Time)
&nbsp;Location: Remote (US-based preferred) Department: Customer Success / Clinical Trials Reports to: VP of Clinical Trials
&nbsp;
Company Overview
Vivalink is a leader in digital health technology, delivering advanced remote data capture solutions for healthcare and clinical research. Our Biometrics Data Platform integrates FDA-cleared medical-grade wearable sensors, cloud-based data services, machine learning algorithms, and clinician software—empowering global organizations to design and deploy remote patient monitoring (RPM) and decentralized clinical trial (DCT) solutions.
We support pharmaceutical companies, CROs, Academia, and healthcare providers with the tools to capture high-quality, real-time physiological data across a wide range of therapeutic areas, including cardiology, neurology, infectious disease, oncology, and rare diseases.
Role Summary
We are seeking a dynamic, detail-oriented Customer Success Manager (CSM) to join our team and help ensure the success of our growing base of clinical research customers. The CSM will serve as the primary point of contact post-sale, responsible for onboarding, project coordination, troubleshooting, relationship development, account penetration, and long-term retention.
You will work closely with cross-functional teams—including Solutions Engineering, Product, Operations, and Sales—to ensure our customers receive an exceptional experience and achieve their desired outcomes.
&nbsp;
Key Responsibilities
<ul>
<li>
Customer Onboarding &amp; Implementation &nbsp;
<ul>
<li>
Coordinate the onboarding process for new clinical trials and RPM deployments, including technical setup, workflow design, training, and user enablement.
</li>
<li>
Collaborate with clients to define project goals, success metrics, and timelines. &nbsp;
</li>
</ul>
</li>
<li>
Account Management &amp; Retention &nbsp;
<ul>
<li>
Serve as the trusted advisor and point of contact for assigned customer accounts and as the liaison between customer and internal teams, such as Product, Sales, Operations and Support.
</li>
<li>
Monitor ongoing study health and proactively identify issues, ensuring timely resolution.
</li>
<li>
Drive renewals and expansions by demonstrating value and anticipating customer needs.
</li>
<li>
Be the voice of the customer within the organization to ensure needs are prioritized. &nbsp;
</li>
</ul>
</li>
<li>
Cross-Functional Coordination &nbsp;
<ul>
<li>
Work with Product, Sales, Operations and Support teams to escalate and resolve customer concerns and issues quickly and effectively.
</li>
<li>
Work with finance to support timely collections.
</li>
<li>
Provide customer feedback to inform roadmap priorities and service improvements. &nbsp;
</li>
</ul>
</li>
<li>
Performance Monitoring &amp; Reporting &nbsp;
<ul>
<li>
Track device usage, data quality, participant adherence, and other key performance indicators.
</li>
<li>
Track progress against defined project goals, success metrics, and timelines
</li>
<li>
Deliver regular reports and business reviews with actionable insights. &nbsp;
</li>
</ul>
</li>
<li>
Advocacy &amp; Relationship Building &nbsp;
<ul>
<li>
Cultivate strong relationships with clinical operations, data managers, investigators, and study coordinators.
</li>
<li>
Promote Vivalink’s broader capabilities to drive customer expansion and satisfaction. &nbsp;
</li>
</ul>
</li>
</ul>
&nbsp;
Qualifications
Required:
<ul>
<li>
5+ years in a Customer Success, Clinical Operations, Project Management, or related client-facing role.
</li>
<li>
Demonstrates a strong ability to understand, communicate, and create alignment with different stakeholders in the client’s organization
</li>
<li>
Strong understanding of digital health, clinical trials, and remote patient monitoring
</li>
<li>
Strong experience working with pharmaceutical, biotech and CRO companies.
</li>
<li>
Excellent written and verbal communication skills.
</li>
<li>
Analytical mindset with the ability to interpret data and derive insights.
</li>
<li>
Comfortable working in a fast-paced, startup-like environment with minimal supervision.
</li>
<li>
Bachelor's degree in Life Sciences, Healthcare, Business, or related field. &nbsp;
</li>
</ul>
Preferred:
<ul>
<li>
Experience with medical devices, wearables, or remote patient monitoring solutions.
</li>
<li>
Familiarity with clinical trial operations, GCP, ICH guidelines, or regulatory considerations (e.g., HIPAA, 21 CFR Part 11).
</li>
<li>
Experience with digital tools such as Hubspot, Jira, Slack, or Confluence.
</li>
<li>
Clinical research certification (e.g., CCRA, CCRC, PMP) is a plus. &nbsp;
</li>
</ul>
&nbsp;
Why Join Vivalink?
<ul>
<li>
Be at the forefront of remote patient monitoring innovation.
</li>
<li>
Work with a collaborative, mission-driven team.
</li>
<li>
Contribute to impactful studies in areas like cardiology, oncology, and infectious diseases.
</li>
<li>
Fully remote and flexible work culture.
</li>
<li>
Competitive salary, equity, and benefits. &nbsp;
</li>
</ul>
Company DescriptionVivalink Campbell, CA Company Silicon Valley-based Vivalink (<a href="http://www.vivalnk.com" target="_blank">www.vivalnk.com</a>) is an innovative connected healthcare devices company in its growth stage. The company develops wearable telemetry devices with integrated biometric sensors designed to continuously monitor human vitals and other indicators for medical and healthcare applications. These devices together with Vivalink’s related healthcare software products and services are offered to enterprise customers under a platform as a service model. Over 300 leading organizations, in more than 50 countries depend on our wearable human vitalssensors, software and services. With great products, more than 20 patents and brilliant people, what we do matters. 
<h3>Company Description</h3>
Vivalink\r\nCampbell, CA\r\nCompany\r\nSilicon Valley-based Vivalink (<a href="http://www.vivalnk.com" target="_blank">www.vivalnk.com</a>) is an innovative connected healthcare devices company in its growth stage. The company develops wearable telemetry devices with integrated biometric sensors designed to continuously monitor human vitals and other indicators for medical and healthcare applications. These devices together with Vivalink’s related healthcare software products and services are offered to enterprise customers under a platform as a service model. Over 300 leading organizations, in more than 50 countries depend on our wearable human vitalssensors, software and services. With great products, more than 20 patents and brilliant people, what we do matters.

Customer Success Manager/Clinical Trials - Remote (Full-Time)

<h3>Job Description</h3>
Job Description
Company introduction:
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.   
We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. 
We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways.
Job overview: 
The Senior Manager, Clinical Quality is responsible for developing and implementing a risk-based GCP (Good Clinical Practice) audit program. This includes planning and conducting audits, coordinating the activities of independent QA auditors, and supporting regulatory inspection readiness activities and regulatory inspections by EMA, FDA and other competent authorities. The role contributes to quality risk management and continuous improvement across clinical trials and related processes.
Location: Remote on the East Coast, USA or hybrid working in our NYC office.
Reports to: Director, Clinical Quality. 
Responsibilities (include but are not limited to): 
<ul>
<li>Provision of GCP QA advice and support to clinical project teams and cross-functional departments to help ensure compliance with applicable regulations and internal quality standards</li>
<li>May act on behalf of the Director, Clinical QA, to provide leadership support and ensure continuity of QA oversight and decision-making</li>
<li>Manage GCP audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Compass quality standards</li>
<li>Coordinate activities of external auditors, during the preparation, conduct and reporting of GCP audits</li>
<li>Support, and conduct when required, risk-based audits of clinical trial sites, both internally and those managed by CROs (Contract Research Organizations), vendors and internal systems ensuring adherence to GCP guidelines, protocols, and regulatory standards</li>
<li>Support the preparation of comprehensive audit reports, identifying potential issues and recommending corrective actions for internal teams and collaborating with CROs to implement necessary changes</li>
<li>Work closely with internal teams to ensure alignment with GCP expectations to address findings and action items from audits</li>
<li>When required, lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness</li>
<li>Proactively assess compliance issues and risks; serve as the expert GCP consultant for issue management &amp; issue escalation</li>
<li>Support partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes</li>
<li>Support the management of GCP inspections within Compass and at vendors/partners of Compass studies and/or processes, as required</li>
<li>Liaise with regulatory agencies (e.g., FDA, EMA) regarding GCP compliance matters</li>
<li>Stay up-to-date on evolving GCP regulations and best practices in clinical trial audit methodology</li>
<li>Participate in the development and implementation of training programs for clinical trial staff, both internal and at CRO partners, on GCP and regulatory compliance</li>
<li>Contribute to the development and review of standard operating procedures (SOPs)</li>
</ul>
Candidate Profile:
<ul>
<li>Degree in a life science field or a related clinical research area (preferred)</li>
<li>GCP QA professional with broad drug experience which spans all clinical phases (Phase I to IV)</li>
<li>Extensive experience in GCP auditing and clinical trial operations</li>
<li>In-depth knowledge of GCP guidelines (ICH-GCP) and regulatory requirements for clinical trials</li>
<li>Strong understanding of clinical trial design, conduct, and data management</li>
<li>Excellent leadership, communication, and interpersonal skills</li>
<li>Strong analytical and problem-solving skills</li>
<li>Ability to work independently and as part of a team</li>
<li>Excellent project management skills</li>
<li>Alignment with the Compass values</li>
</ul>
Benefits &amp; Compensation:
For an overview of our benefits package and compensation information, please visit "Working at Compass". 
Equal opportunities: 
Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. 
UK applicants
We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.
US applicants
Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.
Sponsorship:
Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.
Data Privacy:
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

283 Remote Clinical Trial Manager Jobs