<h3>Job Description</h3>
Job Description
POSITION SUMMARY
The Associate Director, Clinical Trials Services oversees a group of Clinical Biospecimen Operations Managers working on multiple projects/studies focused on delivery of Natera's testing pipeline for Pharma and Consortium/Academic studies where Natera tests are run as part of an externally sponsored clinical trial or a companion diagnostic program. This role provides direct management to individual contributors to ensure delivery of study objectives. Coordinates with management for department resources. Fields management requests, provides resourcing feedback and delegates work accordingly
PRIMARY RESPONSIBILITIES
<ul>
<li>
Lead, build, develop and manage an effective team of professionals dedicated to delivery of externally sponsored oncology studies, including Pharma and/or Consortium/Academic studies. 
</li>
<li>
Is directly responsible for/leads a team that performs: 
</li>
<li>
<ul>
<li>
Maintain oversight of all study operational activities including leading study requirements efforts to drive readiness timelines, kick-off and planning activities, study conduct management within contractual agreements, and closure activities. Generally, oversees phase III or large consortia studies, but may also support or lead phase I/II pharma or small consortia studies. 
</li>
<li>
Regularly monitors the overall health of the study from study start-up through closure, including routine evaluation of key metrics (TAT, TNP), project management of key milestones and activities, and escalation of project risks and mitigation plans both internally as well as to the study sponsor when appropriate.
</li>
</ul>
</li>
<li>
Partner with internal stakeholders from Laboratory Operations, Alliance Management, Product Management, R&amp;D, CLIA Laboratory, Data Management, Business Development, Regulatory Affairs, and Clinical Quality to ensure on-schedule delivery of sample and study management requirements 
</li>
<li>
Work with ClinOps leadership to ensure proactive assignment of resources to Pharma and Consortium/Academic
</li>
<li>
Collaborate with ClinOps leadership and cross-functionally at Natera to troubleshoot high complexity technical and non-technical problems across project delivery, ensure standardization of activities where possible, and enable optimal use of human resources across Natera departments 
</li>
<li>
Represent the Pharma Operations team at cross-functional internal and external joint project level meetings if issues are escalated 
</li>
<li>
Maintain readiness for audits, inspections and monitoring visits 
</li>
<li>
Facilitate the personal development of staff, including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings. Serves as a mentor and guide to junior employees. 
</li>
<li>
Manages and leads a team working on a complex set of objectives (e.g. one or more clinical studies or projects) 
</li>
<li>
Responsible for staffing of assigned projects and for development of direct reports 
</li>
<li>
Manages a team of 2-5 direct reports working on multiple projects or studies
</li>
<li>
Makes recommendations to senior management on human resources, project budget, and department operations and process 
</li>
<li>
Effectively presents to senior management or external stakeholders on matters of critical importance to Natera 
</li>
<li>
Can change the thinking of or gain acceptance from others in sensitive situations without damage to the relationship 
</li>
<li>
Seen as an established leader leader 
</li>
<li>
Proficient people manager 
</li>
<li>
Represents the Clinical Trial Operations department in cross functional interactions 
</li>
<li>
Takes OKRs and business goals and determines the path to deliver results from the team 
</li>
<li>
Makes decisions within the scope of assigned projects or studies with limited input from more senior managers 
</li>
<li>
Spends -30% time managing staff 
</li>
<li>
Performs other duties as assigned 
</li>
</ul>
QUALIFICATIONS: 
<ul>
<li>
Bachelor's Degree or equivalent required in a scientific relevant field, PMP certification preferred 
</li>
<li>
Advanced proficiency in job related technical skills 
</li>
<li>
7 years minimum experience 
</li>
<li>
Demonstrated experience managing and leading people to achieve aggressive timelines with high quality 
</li>
<li>
Highly advanced in the management and execution of clinical studies/trials/labs/ including management of vendors, central labs and/or CROS 
</li>
<li>
Proven record of working effectively with and across business areas (clinical science, medical affairs, research &amp; development, finance, regulatory, legal, sales, contracting, business development, etc.) 
</li>
<li>
Expert in technical knowledge required to lead a Clinical Trial organization 
</li>
<li>
Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
</li>
</ul>
KNOWLEDGE, SKILLS, AND ABILITIES:
<ul>
<li>
Learns and applies in-depth knowledge of Natera's business and corporate objectives to analyze situations and available data in order to make effective recommendations on project status to Sr. Management. 
</li>
<li>
Exercises solid and mature judgment to escalate issues in a timely manner 
</li>
<li>
Keeps senior management apprised of business-critical risks and proactively develops comprehensive mitigation plans 
</li>
<li>
Requires the ability to change the thinking of, or gain acceptance from others in sensitive situations without damage to relationships 
</li>
<li>
Provides feedback to both direct reports and management in a respectful and thoughtful way in order to achieve goals and deliverables aligned with departmental and corporate goals and objectives 
</li>
<li>
Makes independent decisions pertaining to management and execution of assigned projects. Decisions made impact the Clinical Operations organization and Natera's expenditure of additional time, resources and/or funding 
</li>
<li>
Represents assigned projects/studies to Natera Sr. Management 
</li>
<li>
Has frequent contact with external parties (e.g, KOLS or external study Sponsors) and is viewed as a respected representative of Natera 
</li>
<li>
Expertise and current training in Good Clinical Practice (GCP) 
</li>
<li>
Strong project management, organizational and communication skills 
</li>
</ul>
PHYSICAL DEMANDS &amp; WORK ENVIRONMENT: 
<ul>
<li>
Duties are typically performed in an office setting. 
</li>
<li>
This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material. 
</li>
<li>
Duties may require working outside normal working hours (evenings and weekends) at times. 
</li>
</ul>
Travel required for this position: 
No or Yes: If yes state anticipated percent for travel: Up to 25% 
 
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years &amp; depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$121,600—$152,000 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit <a href="http://www.natera.com" target="_blank">www.natera.com</a>.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents. 
Link: <a href="https://www.natera.com/notice-of-data-collection-california-residents/" target="_blank">https://www.natera.com/notice-of-data-collection-california-residents/</a>
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Assoc Dir, Clinical Trial Services

<h3>Job Description</h3>
Job Description
Source One is a consulting services company and we are currently looking for the following individual to work as a consultant to our direct client, a global pharmaceutical company. This position is remote but will be working in the EST time zone.
 
* We are unable to work with third party companies for this role.
 
Summary: CTMS (Clinical Trial Management System) Business Support Analyst is responsible for supporting systems/processes for any system supported by Clinical Trials Management Solutions team and mainly includes study build activities in CTMS, troubleshoot issues, ensure high quality data and smooth integration between CTMS and other systems.
 
Qualifications: • Prior experience with Clinical Trial Management Systems (CTMS) such as Medidata, Siebel, Veeva Vault or any other • 3+ years of relevant experience • Knowledge of the Clinical Trial Management process • Proficient in using MS Office Suite of applications • Should have strong problem-solving skills and good communication skills • Able to run SQL queries from Oracle or other SQL-based database
 
Responsibilities: • Work with Study Teams and partners during study build process to create/maintain the following in CTMS: o Study, Country, Site, Contacts, and Institution records o Create and set up templates such as Health Authority, IRB/IEC, Financial Disclosure, Subject Visit, Visit/Trip Report o Update system dropdown values o Create/Update assignments, configurations, properties, attributes, triggers, and parameters in the system o User administration o Import/Export templates o Add Payees and study triggers o Visit Schedules o Subject deviations/central findings o Any other general study build activities o Troubleshoot integration errors between CTMS and other applications • Assist in analyzing large data sets • Assist with UAT activities • Provide general business support for CTMS, and other applications supported by the Clinical Trial Management Solutions team • Create/generate reports • Run SQL queries • Support ticket generation/creation and maintenance (tracking of issues/requests) • Create/update reference and training materials/documentation • Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document • Primary interfaces: Reports to AD, Manager, or Lead of Clinical Trial Management Business Support, Study Teams, Champions, Transition Agents, Other support team members, IT • Other Interfaces: External vendors as necessary (e.g. Medidata vendor) • Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements
Company DescriptionA WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical &amp; Healthcare, Defense, Technology, Financial Services, Retail &amp; Manufacturing, and Energy &amp; Transportation industries nationwide. 
<h3>Company Description</h3>
A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical &amp; Healthcare, Defense, Technology, Financial Services, Retail &amp; Manufacturing, and Energy &amp; Transportation industries nationwide.

CTMS (Clinical Trial Management System) Business Support Analyst

<h3>Job Description</h3>
Job DescriptionSalary: $125,000 - $140,000 
We are looking for an experienced Associate Director of Operations to join our team!
 
Are you a self-driven leader who can provide excellent leadership and oversight to the Operations team while promoting team effort and accountability? Can you quickly respond to unexpected changes and make sound decisions? Someone who is able to see the bigger picture without losing sight of the day-to-day tasks? If so, keep reading!
This role is ideal for an individual who can motivate cross-functional teams to collaboratively work together to produce the best quality outcome and foster positive relationships. 
 
Responsibilities:
Strategic Input
<ul>
<li>Support the Director of Operations and Executive Director in defining and carrying forward strategic objectives at the organizational level.</li>
<li>Support the development and implementation of annual goals and performance metrics for the CPC Operations teams (Clinical Operations, Site Operations, and Endpoint &amp; Specialty Services [ESS]) in collaboration with functional area leaders and the Leadership Committee.</li>
<li>Ensure proactive assessment and identification of project issues by functional area leaders and support teams in developing and implementing risk mitigation strategies.</li>
</ul>
Leadership and Management
<ul>
<li>Provide oversight, management, and leadership for Operations. </li>
<li>Supervise, coach, and mentor team members, setting clear job expectations, assessing training needs, and ensuring team members receive necessary training.</li>
</ul>
Quality and Compliance
<ul>
<li>Oversee the quality, accuracy, and timeliness of deliverables from the Operations teams. </li>
<li>Ensure CPC Operations teams compliance with applicable policies, standard operating procedures (SOPs), work instructions (WIs), and relevant regulations and guidelines.</li>
<li>Review, and approve applicable policies, SOPs, and WIs. Work closely with team members to create and improve these documents.</li>
</ul>
Project Management
<ul>
<li>Function as an Executive Clinical Operations Manager or Project Manager for projects, as needed.</li>
<li>Provide mentoring, support, and backup for all relevant project activities.</li>
<li>Provide regular updates to supervisors on staff, key performance indicators, timelines, and deliverables.</li>
<li>Work with the team to identify and implement best practices for optimizing performance and increasing efficiencies.</li>
</ul>
Resource Allocation
<ul>
<li>Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Operations.</li>
</ul>
Business Development
<ul>
<li>Assist Business Development with benchmarking for budgets and development of proposals and service agreements. </li>
</ul>
Executive Management
<ul>
<li>Support the Director of Operations, Director of Informatics, Biostatistics and Data Management and Leadership Committee to ensure optimal procurement, implementation, and adoption of systems used to support the CPC Operations team; identify and support system owners.</li>
<li>Oversee the accurate and timely recognition of project specific revenue; ensure accurate revenue forecasting for all assigned projects. </li>
</ul>
Perform additional activities as required.
Qualifications:
 
<ul>
<li>BA/BS in a scientific field. Advanced degree preferred. </li>
<li>A minimum of 10 years of experience clinical research (or equivalent) experience</li>
<li>A minimum of 5 years in clinical trial management (or equivalent) experience</li>
<li>A minimum of 3 years of supervisory experience</li>
<li>Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials</li>
<li>Proficiency in MS Office including Project, PowerPoint, Word, and Excel</li>
<li>Excellent interpersonal communication skills</li>
<li>Strong analytical and reasoning skills</li>
<li>Ability to work as a member of a team and to organize, instruct, and supervise staff while promoting group effort and achievement</li>
<li>Ability to manage conflicts and resolve problems effectively</li>
<li>Commitment to accountability and passion for the organization's mission, vision, and values</li>
<li>Ability and willingness to travel up to 15%</li>
</ul>
 
Targeted Compensation:$125,000 - $140,000 annually 
 
Deadline to Apply: August1, 2025
 
About CPC: 
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas.With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
 
CPC has expertise in managing clinical trials from a variety of funding sources including industry, NIH, and Investigator Initiated trials. 
 
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy.<a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a> 
CPC offers: 
 Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) 
 Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) 
 11 paid holidays 
 15 - 25 vacation days based on years of service 
 Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 
 In-suite exercise and relaxation room 
 Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) 
 Flexible and remote work schedules 
 
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.
 remote work

Associate Director of Clinical Trial Operations

<h3>Job Description</h3>
Job DescriptionSalary: $125,000 - $140,000 
We are looking for an experienced Associate Director of Operations to join our team!
 
Are you a self-driven leader who can provide excellent leadership and oversight to the Operations team while promoting team effort and accountability? Can you quickly respond to unexpected changes and make sound decisions? Someone who is able to see the bigger picture without losing sight of the day-to-day tasks? If so, keep reading!
This role is ideal for an individual who can motivate cross-functional teams to collaboratively work together to produce the best quality outcome and foster positive relationships. 
 
Responsibilities:
Strategic Input
<ul>
<li>Support the Director of Operations and Executive Director in defining and carrying forward strategic objectives at the organizational level.</li>
<li>Support the development and implementation of annual goals and performance metrics for the CPC Operations teams (Clinical Operations, Site Operations, and Endpoint &amp; Specialty Services [ESS]) in collaboration with functional area leaders and the Leadership Committee.</li>
<li>Ensure proactive assessment and identification of project issues by functional area leaders and support teams in developing and implementing risk mitigation strategies.</li>
</ul>
Leadership and Management
<ul>
<li>Provide oversight, management, and leadership for Operations. </li>
<li>Supervise, coach, and mentor team members, setting clear job expectations, assessing training needs, and ensuring team members receive necessary training.</li>
</ul>
Quality and Compliance
<ul>
<li>Oversee the quality, accuracy, and timeliness of deliverables from the Operations teams. </li>
<li>Ensure CPC Operations teams compliance with applicable policies, standard operating procedures (SOPs), work instructions (WIs), and relevant regulations and guidelines.</li>
<li>Review, and approve applicable policies, SOPs, and WIs. Work closely with team members to create and improve these documents.</li>
</ul>
Project Management
<ul>
<li>Function as an Executive Clinical Operations Manager or Project Manager for projects, as needed.</li>
<li>Provide mentoring, support, and backup for all relevant project activities.</li>
<li>Provide regular updates to supervisors on staff, key performance indicators, timelines, and deliverables.</li>
<li>Work with the team to identify and implement best practices for optimizing performance and increasing efficiencies.</li>
</ul>
Resource Allocation
<ul>
<li>Ensure appropriate resourcing and personnel allocation for evolving business and project needs within Operations.</li>
</ul>
Business Development
<ul>
<li>Assist Business Development with benchmarking for budgets and development of proposals and service agreements. </li>
</ul>
Executive Management
<ul>
<li>Support the Director of Operations, Director of Informatics, Biostatistics and Data Management and Leadership Committee to ensure optimal procurement, implementation, and adoption of systems used to support the CPC Operations team; identify and support system owners.</li>
<li>Oversee the accurate and timely recognition of project specific revenue; ensure accurate revenue forecasting for all assigned projects. </li>
</ul>
Perform additional activities as required.
Qualifications:
 
<ul>
<li>BA/BS in a scientific field. Advanced degree preferred. </li>
<li>A minimum of 10 years of experience clinical research (or equivalent) experience</li>
<li>A minimum of 5 years in clinical trial management (or equivalent) experience</li>
<li>A minimum of 3 years of supervisory experience</li>
<li>Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations for conducting clinical drug trials</li>
<li>Proficiency in MS Office including Project, PowerPoint, Word, and Excel</li>
<li>Excellent interpersonal communication skills</li>
<li>Strong analytical and reasoning skills</li>
<li>Ability to work as a member of a team and to organize, instruct, and supervise staff while promoting group effort and achievement</li>
<li>Ability to manage conflicts and resolve problems effectively</li>
<li>Commitment to accountability and passion for the organization's mission, vision, and values</li>
<li>Ability and willingness to travel up to 15%</li>
</ul>
 
Targeted Compensation:$125,000 - $140,000 annually 
 
Deadline to Apply: November1, 2025
 
About CPC: 
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas.With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
 
CPC has expertise in managing clinical trials from a variety of funding sources including industry, NIH, and Investigator Initiated trials. 
 
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy.<a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a> 
CPC offers: 
 Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) 
 Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) 
 11 paid holidays 
 15 - 25 vacation days based on years of service 
 Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 
 In-suite exercise and relaxation room 
 Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) 
 Flexible and remote work schedules 
 
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.

<h3>Job Description</h3>
Job Description
This is a remote position.
The Clinical Research Manager (CRM) is responsible for the strategic and operational oversight of clinical trials conducted across various phases. This role ensures that studies are executed in compliance with regulatory requirements, GCP/ICH guidelines, and internal SOPs. The CRM manages cross-functional teams, monitors timelines and budgets, and acts as the primary liaison between investigators, CROs, vendors, and internal stakeholders. Key Responsibilities: Lead the planning, execution, and management of clinical trials across multiple therapeutic areas and phases. Oversee site selection, study start-up, patient recruitment, data collection, and close-out activities. Ensure compliance with FDA, ICH-GCP, and other applicable regulatory standards. Develop and maintain project timelines, budgets, and resource plans. Supervise and mentor Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), and study coordinators. Review and approve study documentation including protocols, CRFs, informed consent forms, and monitoring reports. Coordinate with cross-functional teams including regulatory affairs, data management, biostatistics, and medical writing. Manage vendor and CRO relationships, including contract negotiations and performance monitoring. Track and report on study metrics and provide regular updates to senior leadership. Oversee the preparation and conduct of audits and regulatory inspections. Minimum Qualifications: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (Master’s or Ph.D. preferred). Minimum of 5–7 years of experience in clinical research, including 2+ years in a managerial or supervisory role. In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and regulatory requirements. Proven experience managing Phase I-IV trials across multiple therapeutic areas. Strong project management, leadership, and team coordination skills. Excellent written and verbal communication abilities. Proficiency with clinical trial software (e.g., CTMS, EDC, eTMF platforms). Ability to travel up to 20% as needed. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. 
E-Verify Participation: 
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.

Clinical Research Manager

<h3>Job Description</h3>
Job Description
This is a remote position.
The Clinical Project Manager (CPM) is responsible for leading and managing all aspects of clinical trials from initiation through closeout. This includes ensuring that clinical projects are conducted in compliance with applicable regulatory requirements, company SOPs, timelines, and budget. The CPM will serve as the primary point of contact for cross-functional teams, vendors, and sponsors (if applicable), ensuring streamlined communication and timely issue resolution throughout the project lifecycle. Key Responsibilities: Develop, manage, and oversee clinical trial project plans including timelines, milestones, budgets, and resource allocation. Serve as the primary liaison between internal teams, clinical research sites, CROs, vendors, and external partners. Lead cross-functional team meetings and coordinate study activities such as site selection, study start-up, monitoring, and close-out. Ensure adherence to GCP, ICH guidelines, regulatory standards, and company SOPs throughout study conduct. Monitor progress against timelines and budget; proactively identify risks and implement mitigation strategies. Oversee vendor performance and manage contract deliverables for CROs, central labs, data management providers, etc. Track clinical trial metrics and prepare regular status reports for internal leadership and/or sponsors. Support regulatory and audit readiness, including contributing to study documentation and inspection preparation. Participate in protocol development, CRF design, and review of key trial documents (e.g., ICF, SAP, CSR). Minimum Qualifications: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (Master’s or PMP certification a plus). Minimum of 5 years of experience in clinical research, including 2+ years in a project management role. Strong understanding of GCP, ICH guidelines, and clinical trial regulatory requirements. Proven ability to manage multi-site and/or global studies across various phases (Phase I–IV). Excellent organizational, problem-solving, and leadership skills. Strong interpersonal and written communication skills. Proficiency with clinical trial management systems (CTMS), MS Project, and Microsoft Office Suite. In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth. Be part of our network of Subject Matter Experts. E-Verify Participation: Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.

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>
Qualifications 
Minimum Qualifications:
<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 Description
Customer Success Manager – Remote (Full-Time)
&nbsp;Location: Remote (US-based preferred) Department: Customer Success / Clinical Trials Reports to: VP of Clinical Trials
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.
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>
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>
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 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 
The CRA II advances AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging advanced capabilities to drive industry-leading performance. The CRA II partners with investigators and site staff to build meaningful, effective engagements that position AbbVie as the sponsor of choice in clinical trials. The role focuses on site clinical research by ensuring proper trial conduct, while continually working to improve data integrity, compliance, overall study performance, and the customer experience.
Responsibilities:
<ul>
<li>Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.</li>
<li>Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.</li>
<li>Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.</li>
<li>Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.</li>
<li>Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.</li>
<li>Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.</li>
<li>May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.</li>
<li>Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.</li>
<li>Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.</li>
<li>Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.</li>
<li>Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.</li>
<li>Ensures audit and regulatory inspection readiness at assigned clinical site at all times.</li>
<li>Manages investigator payments as per executed contract obligations, as applicable.</li>
</ul>
Qualifications 
Minimum Qualifications:
<ul>
<li>Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. (CRA experience)</li>
<li>Familiar with risk-based monitoring approach, onsite and offsite monitoring.</li>
</ul>
Preferred Qualifications:
<ul>
<li>Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.</li>
<li>Knowledge of appropriate therapeutic area indications (oncology) is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.</li>
<li>Experience as a study coordinator&nbsp;</li>
</ul>
Other Required Skills:
<ul>
<li>Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.</li>
<li>Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.</li>
<li>Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.</li>
<li>Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.</li>
<li>Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.</li>
<li>Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.</li>
<li>Acts with integrity in accordance with AbbVie code of business conduct and leadership values.</li>
<li>Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.</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>

210 Remote Clinical Trial Manager Jobs