<h3>Job Description</h3>
Job Description
About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking a highly organized and detail-oriented Clinical Research Study Manager to provide operational oversight and coordination of multiple NIH-funded observational tuberculosis studies conducted at a number of international sites. This role supports U.S.-based leadership during a staffing transition and ensures smooth communication and collaboration between domestic and overseas research teams. Periodic international travel will be required to gain first-hand understanding of study operations, challenges, and systems. WHY VITALIEF?&nbsp;
<ul>
<li>Contribute to advancing scientific discoveries that improve patient lives.</li>
<li>PEOPLE FIRST culture with opportunities for growth and innovation.</li>
<li>Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans.</li>
<li>Market-competitive salary, commensurate with experience.</li>
</ul>
 Work Location: 100% Remote (Company based in Newark, NJ) Residency Requirement: Candidates must reside in NY, NJ, CT, or PA Travel Requirement: International travel approximately every 3 months for 2-week visits (totaling 8 weeks annually) to sites in North America, South America, Africa, Eastern Europe, and Asia (including Peru, Brazil, Moldova, Uganda, Kenya, South Africa, India, Vietnam, Indonesia, China, and the Philippines). Key Responsibilities:
<ul>
<li>Oversee day-to-day management and coordination of multiple ongoing international observational studies in infectious diseases (tuberculosis).</li>
<li>Serve as the primary liaison between U.S.-based staff (managing two coordinators) and international trial site teams, ensuring clear communication and timely issue resolution.</li>
<li>Work closely with trial site PI’s, coordinators, clinicians, laboratory scientists, and U.S.-based staff to align study goals and deliverables.</li>
<li>Ensure operational excellence, compliance with regulatory standards, and adherence to NIH funding requirements.</li>
<li>Support transparent communication across international teams by leading team meetings to provide project updates for investigators and leadership.</li>
<li>Oversee study progress, budgets, resources, and milestones; identify and resolve operational challenges.</li>
<li>Support investigators and site teams in study execution, data quality assurance, and reporting consistency.</li>
<li>Facilitate regular project meetings and prepare updates for investigators and senior leadership.</li>
<li>Facilitate study operations, troubleshoot challenges, and ensure high-quality data collection and reporting.</li>
<li>Conduct international site visits and monitoring trips as needed to assess study performance and foster collaboration across global teams.</li>
</ul>
Qualifications:
<ul>
<li>Master’s degree in life sciences, public health, or a related field.</li>
<li>Minimum of 3 years of experience managing clinical research studies, preferably in infectious diseases or global health.</li>
<li>Proven success building and maintaining strong, collaborative relationships with international research sites and cross-cultural teams.</li>
<li>Exceptional organizational, project management, people management, and problem-solving skills with demonstrated ability to manage multiple priorities.</li>
<li>Excellent communication and interpersonal skills, with the ability to navigate collaborations across time zones and diverse cultures.</li>
<li>Culturally sensitive, flexible, and resourceful in addressing challenges in global health research settings.</li>
<li>Proactive, adaptable, and detail-oriented professional who thrives in complex, dynamic environments.</li>
<li>Familiarity with NIH-funded research and related regulatory requirements preferred.</li>
<li>Proficient in Microsoft Word, Excel, Access, and PowerPoint; experience with REDCap is a plus.</li>
<li>Ability and willingness to travel internationally up to 30% of the time.</li>
</ul>
PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. &nbsp;International travel up to 30%.
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Clinical Research Study Manager

<h3>Job Description</h3>
Job DescriptionRegional Manager of Clinical Research Reports to: National Director&nbsp; Location: Flexible / Remote with travel to research sites nationwide Employment Type: Full-Time, Exempt Position Summary We are seeking a Regional Manager of Clinical Research to oversee and elevate our growing network of clinical research sites. In this key leadership role, you will drive operational excellence, strategic growth, and quality performance across multiple therapeutic areas. The Regional Manager of Clinical Research serves as an operational and clinical research leader responsible for the oversight, strategic growth, and performance of the organization’s network of clinical research sites. This role ensures operational excellence, regulatory compliance, and high-quality study execution across all therapeutic areas and enrolment. The Manager will review clinical operations, budgets, SOPs, site performance management, and sponsor/CRO relationships to achieve the organization’s business and scientific goals. Additional responsibilities include: 
<ul>
<li>Develop and implement a national strategy for clinical research site operations, aligning with organizational goals and growth objectives.</li>
<li>Drive site expansion initiatives, including acquisition, partnership, and start-up of new research centers.</li>
<li>Serve as a liaison between senior management, site directors, investigators, and external partners (sponsors, CROs, and IRBs).</li>
<li>Ensure adherence to FDA regulations, ICH-GCP guidelines, and all applicable local, state, and federal laws.</li>
<li>Oversee internal quality assurance programs, sponsor audits, and regulatory inspections.</li>
<li>Develop and maintain quality improvement initiatives, CAPA processes, and compliance training programs.</li>
<li>Support proposal development, feasibility assessments, and bid defense meetings.</li>
<li>Strengthen and expand relationships with key sponsors and CRO partners to secure new clinical trial opportunities.</li>
<li>Represent the organization at industry conferences and networking events to promote visibility and credibility.</li>
</ul>
Qualifications Education: 
<ul>
<li>Advanced business or management degree (MBA or MPH) preferred. MD, PhD, PharmD, RN, or advanced degree in life sciences or healthcare will be considered.</li>
</ul>
Experience: 
<ul>
<li>Minimum 5+ years of progressive leadership experience in clinical research operations, preferably within an SMO, CRO, or multi-site network.</li>
<li>Strong understanding of FDA regulations, ICH-GCP, and clinical site management practices.</li>
<li>Demonstrated experience leading teams, implementing operational systems, and driving growth.</li>
<li>Experience with Phase I–IV clinical trials across multiple therapeutic areas preferred.</li>
</ul>
Skills and Competencies: 
<ul>
<li>Exceptional leadership, communication, and interpersonal skills.</li>
<li>Strategic and analytical thinker with strong business acumen.</li>
<li>Proven ability to build and maintain high-level sponsor and investigator and study team relationships.</li>
<li>Proficient in clinical trial management systems (CTMS), EDC, and performance analytics tools.</li>
<li>Ability to travel up to 50% nationwide.</li>
</ul>
Compensation and Benefits 
<ul>
<li>Competitive -level salary</li>
<li>Comprehensive health coverage</li>
<li>Competitive 401(k) with % company match</li>
<li>Paid time off and professional development support</li>
<li>Travel reimbursement and support resources</li>
</ul>
 About the Organization Ki Health Partners, LLC, Site Management Organization (SMO) division is dedicated to advancing clinical research through operational excellence and patient-centered care. With a growing network of premier clinical sites across the United States, we partner with leading sponsors and CROs to accelerate the delivery of innovative therapies. Our mission is to improve human health by ensuring that every study and sites meets the highest standards of quality, ethics, and scientific rigor.

Regional Manager of Clinical Research

<h3>Job Description</h3>
Hello,
 
This is Jyoti and I’m a professional Recruiter with Vlink.
 
VLink, founded in 2006, is a leading global provider of software engineering services with next-gen technologies and best-in-class talent. Our Headquarters are in the U.S, and we have offices in 7+ countries from North America-Europe to APAC, with expansion plans in the Middle East. With over 1,000 employees working globally, VLink has helped SMBs, and large enterprises achieve their business goals, and gained the trust of Fortune-250 companies. VLink is ‘Great Place to Work® Certified™' and has been a consistent winner as- Best Places to Work in CT. Trust, collaboration, and accountability are the three elements that are at the core of VLink’s work culture. We value our professionals, providing comprehensive benefits and the opportunity for growth.
 
Job Descriptions:
Role: Veeva System Manager – Vault Clinical + SAS Clinical + Snowflake Commercial
Experience: 8-12 Year
Primary Skills: Vault Clinical + SAS Clinical + Snowflake Commercial
Additional Skills: GxP, 21 CFR Part 11, SAS
Education: Bachelors
Relocation: Yes
Additional Information:
<ul>
<li>Working hours: 40 hours</li>
<li>Remote/Hybrid/Onsite? Redwood City, Hybrid</li>
</ul>
 
About VLink: Started in 2006 and headquartered in Connecticut, VLink is one of the fastest growing digital technology services and consulting companies. Since its inception, our innovative team members have been solving the most complex business, and IT challenges of our global clients.
Job Description:
Role Summary:
We are seeking a Veeva System Manager with expertise in Vault Clinical, SAS Clinical, and Snowflake Commercial platforms. This role combines system administration with business engineering responsibilities to drive clinical and commercial data initiatives.
Key Responsibilities:
<ul>
<li>Administer and manage Veeva Vault Clinical configurations, user roles, and workflows.</li>
<li>Oversee integration between Vault Clinical and SAS Clinical for trial data analytics.</li>
<li>Support commercial data flows and reporting between Vault and Snowflake environments.</li>
<li>Ensure system compliance with GxP, 21 CFR Part 11, and internal validation standards.</li>
<li>Lead validation documentation, change control, and audit readiness activities.</li>
</ul>
 
System Engineer Responsibilities:
<ul>
<li>Drive business initiatives by collaborating with Clinical and Commercial business leaders.</li>
<li>Gather and analyze requirements through stakeholder interviews and workshops.</li>
<li>Conduct cross-functional meetings to align teams on system capabilities and enhancements.</li>
<li>Act as a liaison between business and technical teams to ensure seamless implementation.</li>
</ul>
 
Required Skills:
<ul>
<li>Strong experience with Veeva Vault Clinical, SAS Clinical, and Snowflake.</li>
<li>Knowledge of clinical trial workflows and commercial analytics.</li>
<li>Experience in system integration, data governance, and compliance.</li>
<li>Excellent communication and stakeholder engagement skills.</li>
</ul>

Veeva System Manager - Vault Clinical + SAS Clinical + Snowflake Commercial

<h3>Job Description</h3>
Job Description Position Summary: The Recruitment Manager is responsible for designing, implementing, and managing patient recruitment and retention strategies for all research trials across multiple clinical research sites. In addition, the recruitment manager will be responsible for all centralized company advertising, including managing website maintenance, CTMS integrations, and social media platforms. This role ensures that enrollment targets are met while maintaining a positive patient experience. Job Relationships
<ul>
<li>Reports directly to the Director of Strategy and Operations and indirectly to the Urology America leadership.&nbsp; This role is also responsible to the individual market presidents, the Principal Investigators of each trial, and the physician partners of each practice.&nbsp; </li>
<li>Collaborates with clinical providers, advertising vendors, site staff, clinic patient navigators, sponsors, and the regulatory team.</li>
</ul>
Reporting to this Position: Recruitment Specialists Role Qualifications
<ul>
<li>Bachelor’s degree in healthcare, marketing, or related field.</li>
<li>3–5 years clinical trial recruitment experience.</li>
<li>Previous experience creating and managing advertising media, placing advertising media, following IRB processes surrounding advertising, and CTMS integrations with advertising.</li>
<li>Strong leadership and project management skills.</li>
<li>Data-driven approach with ability to analyze recruitment metrics and trends.</li>
<li>Exceptional time management skills and the ability to prioritize varying trial recruitment timelines.</li>
<li>Excellent communication skills and the ability to interact with all levels of management, staff, vendors, sponsors, and providers.</li>
</ul>
Essential Job Duties:&nbsp;
<ul>
<li>Proactively develop and lead the execution of all companywide recruitment campaigns tailored to study and site needs.</li>
<li>Collaborate with local market patient navigators to utilize local work flows and EMR capabilities to support recruitment activities.</li>
<li>Manage all aspects of the CTMS recruitment builds.</li>
<li>Primary liaison to any marketing groups or advertising vendors used for supplying or creating research advertising content.</li>
<li>Responsible for managing website decision making and implementation, ensuring good communication between the marketing and leadership team.</li>
<li>Works together with local markets to support pre-screening, scheduling, and patient screening workflows.</li>
<li>Partner with marketing to create IRB-approved outreach materials and community engagement initiatives.</li>
<li>Develop and lead external patient engagement activities for local markets.</li>
<li>Creates general and study specific advertising, social media posts, and other recruitment media as needed.</li>
<li>Monitor recruitment performance metrics and adjust strategies to optimize enrollment.</li>
<li>Train and supervise recruitment specialists, including ensuring implementation of weekly recruitment plans.</li>
<li>Build community relationships with healthcare providers, patient advocacy groups, and referral networks.</li>
<li>Ensure compliance with GCP, IRB, and HIPAA requirements in all recruitment activities.</li>
<li>Work closely with regulatory team to ensure IRB submissions are created and approved for all study specific advertising.</li>
<li>Responsible for frequent recruitment metric reporting to leadership.</li>
</ul>
Performance Requirements:&nbsp; Knowledge
<ul>
<li>Knowledge of clinical research in a specialty setting; medical practice clinical and administrative systems, clinical research software, and sponsor requirements for clinical trial advertising.</li>
<li>Understanding of medical terminology.&nbsp; </li>
</ul>
Skills
<ul>
<li>Ability to use multi-line phone systems and relevant computer systems.</li>
<li>Interpersonal and communication both with internal staff and external customers.</li>
<li>Skill in evaluating and implementing recruitment plans</li>
<li>Time Management.</li>
</ul>
Abilities
<ul>
<li>Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.</li>
<li>Elicit appropriate information for patients to clinic staff.</li>
<li>Ability to read and understand information and ideas presented in writing.</li>
<li>Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.</li>
</ul>
Physical Demands and Work Environment:&nbsp; The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job.&nbsp; Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:
<ul>
<li>hysical demands: Involves sitting approximately 70-90 percent of the day, walking or standing for the remainder. Work may require lifting up to 25 pounds.&nbsp;&nbsp; </li>
<li>Work environment: Hybrid remote, office setting</li>
</ul>
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Clinical Research Recruitment Manager

<h3>Job Description</h3>
Job Description Position Summary: The Recruitment Manager is responsible for designing, implementing, and managing patient recruitment and retention strategies for all research trials across multiple clinical research sites. In addition, the recruitment manager will be responsible for all centralized company advertising, including managing website maintenance, CTMS integrations, and social media platforms. This role ensures that enrollment targets are met while maintaining a positive patient experience. Job Relationships
<ul>
<li>Reports directly to the Director of Strategy and Operations and indirectly to the Urology America leadership.&nbsp; This role is also responsible to the individual market presidents, the Principal Investigators of each trial, and the physician partners of each practice.&nbsp; </li>
<li>Collaborates with clinical providers, advertising vendors, site staff, clinic patient navigators, sponsors, and the regulatory team.</li>
</ul>
Reporting to this Position: Recruitment Specialists Role Qualifications
<ul>
<li>Bachelor’s degree in healthcare, marketing, or related field.</li>
<li>3–5 years clinical trial recruitment experience.</li>
<li>Previous experience creating and managing advertising media, placing advertising media, following IRB processes surrounding advertising, and CTMS integrations with advertising.</li>
<li>Strong leadership and project management skills.</li>
<li>Data-driven approach with ability to analyze recruitment metrics and trends.</li>
<li>Exceptional time management skills and the ability to prioritize varying trial recruitment timelines.</li>
<li>Excellent communication skills and the ability to interact with all levels of management, staff, vendors, sponsors, and providers.</li>
</ul>
Essential Job Duties:&nbsp;
<ul>
<li>Proactively develop and lead the execution of all companywide recruitment campaigns tailored to study and site needs.</li>
<li>Collaborate with local market patient navigators to utilize local work flows and EMR capabilities to support recruitment activities.</li>
<li>Manage all aspects of the CTMS recruitment builds.</li>
<li>Primary liaison to any marketing groups or advertising vendors used for supplying or creating research advertising content.</li>
<li>Responsible for managing website decision making and implementation, ensuring good communication between the marketing and leadership team.</li>
<li>Works together with local markets to support pre-screening, scheduling, and patient screening workflows.</li>
<li>Partner with marketing to create IRB-approved outreach materials and community engagement initiatives.</li>
<li>Develop and lead external patient engagement activities for local markets.</li>
<li>Creates general and study specific advertising, social media posts, and other recruitment media as needed.</li>
<li>Monitor recruitment performance metrics and adjust strategies to optimize enrollment.</li>
<li>Train and supervise recruitment specialists, including ensuring implementation of weekly recruitment plans.</li>
<li>Build community relationships with healthcare providers, patient advocacy groups, and referral networks.</li>
<li>Ensure compliance with GCP, IRB, and HIPAA requirements in all recruitment activities.</li>
<li>Work closely with regulatory team to ensure IRB submissions are created and approved for all study specific advertising.</li>
<li>Responsible for frequent recruitment metric reporting to leadership.</li>
</ul>
Performance Requirements:&nbsp; Knowledge
<ul>
<li>Knowledge of clinical research in a specialty setting; medical practice clinical and administrative systems, clinical research software, and sponsor requirements for clinical trial advertising.</li>
<li>Understanding of medical terminology.&nbsp; </li>
</ul>
Skills
<ul>
<li>Ability to use multi-line phone systems and relevant computer systems.</li>
<li>Interpersonal and communication both with internal staff and external customers.</li>
<li>Skill in evaluating and implementing recruitment plans</li>
<li>Time Management.</li>
</ul>
Abilities
<ul>
<li>Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.</li>
<li>Elicit appropriate information for patients to clinic staff.</li>
<li>Ability to read and understand information and ideas presented in writing.</li>
<li>Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.</li>
</ul>
Physical Demands and Work Environment:&nbsp; The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job.&nbsp; Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:
<ul>
<li>hysical demands: Involves sitting approximately 70-90 percent of the day, walking or standing for the remainder. Work may require lifting up to 25 pounds.&nbsp;&nbsp; </li>
<li>Work environment: Hybrid remote, office setting</li>
</ul>
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<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 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.

<h3>Job Description</h3>
Job Description
This is a remote position.
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements. This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution. Key Responsibilities: Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol. Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines. Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams. Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations. Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP). Manage database lock activities and contribute to the preparation of clinical study reports (CSRs). Serve as the primary point of contact for data management vendors and oversee their deliverables. Participate in study team meetings and provide status updates related to data quality and timelines. Support audit readiness and participate in regulatory inspections when required. Minimum Qualifications: Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field. Advanced degree is a plus. Minimum of 3–5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment. Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap). Strong understanding of ICH-GCP, FDA regulations, and CDISC standards. Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug). Excellent organizational, analytical, and problem-solving skills. Strong communication and collaboration skills across cross-functional teams. Experience working on global, multi-site clinical trials preferred. 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 Data Manager

<h3>Job Description</h3>
Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a&nbsp;award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate.&nbsp;We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. &nbsp; Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn. Roles and Responsibilities:
<ul>
<li>Confidently displays excellent internal and external customer service.</li>
<li>Has proficiency and knowledge of multiple EDC systems; applies this knowledge to advise customers regarding the best-fit EDC solution.</li>
<li>Interacts directly and independently with DM suppliers including EDC and/ or IWR; expert communicator, where necessary negotiating with supplier to meet business needs.</li>
<li>Interacts directly and independently with client to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationships.</li>
<li>Responsible for entire data management process from study set-up to study close-out; primary contact on all data management study-specific issues; has high-level knowledge of drug development as it pertains to data management.</li>
<li>Actively participates in protocol review with clients, providing suggestions regarding ability to capture protocol information in database successfully.</li>
<li>Strong understanding of GCP/ ICH guidelines and FDA regulations, as applicable to data management.</li>
<li>Creates training exercises; serves as mentor and trains new clinical data managers.</li>
<li>Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits.</li>
<li>Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan.</li>
<li>Preparation of any study tracking and metric reports for use by the study team.</li>
<li>Oversees execution of user acceptance testing (UAT) of study-specific systems and applications.</li>
<li>Interacts with cross-functional team members to ensure completion of all timelines and studies.</li>
<li>Participates in data management and/or organizational initiatives.</li>
<li>Initiates SOP updates and provide specifications for DM systems/ tools and process enhancements.</li>
<li>May act as resource for QC activities in collaboration with QC Coordinator.</li>
<li>Understands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures, etc.).</li>
<li>Confident, positive attitude displayed towards clients and projects.</li>
<li>Willingness to learn new skills and expand knowledge of drug development.</li>
<li>Leads data management projects with little management oversight.</li>
<li>Ability to work independently and resolve issues.</li>
<li>Ability to clearly articulate the DM services offered at company, including pros and cons of various DM approaches (specific to a client or operating model). To include potential attendance at (web or remote) capabilities and bid defense meetings.</li>
</ul>
Requirements:
<ul>
<li>Bachelor’s or Master’s Degree in scientific or health care field preferred with industry or relevant experience.</li>
<li>5+ years’ experience in data management field with a minimum of 1 year of experience leading projects.</li>
<li>Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.</li>
<li>Extensive knowledge of Clinical Operations SOPs and Working Practices.</li>
<li>Excellent verbal and written communication skills, as well as, interpersonal and organizational skills.</li>
</ul>
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Senior Clinical Data Manager

<h3>Job Description</h3>
Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?&nbsp;MMS is a&nbsp;award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate.&nbsp;We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. &nbsp; Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit&nbsp;<a href="http://www.mmsholdings.com&nbsp;or" target="_blank">www.mmsholdings.com&nbsp;or</a> follow MMS on&nbsp;LinkedIn. Roles and Responsibilities:
<ul>
<li>Confidently displays excellent internal and external customer service.</li>
<li>Has proficiency and knowledge of multiple EDC systems; applies this knowledge to advise customers regarding the best-fit EDC solution.</li>
<li>Interacts directly and independently with DM suppliers including EDC and/ or IWR; expert communicator, where necessary negotiating with supplier to meet business needs.</li>
<li>Interacts directly and independently with client to coordinate all facets of projects; expert communicator; builds and maintains strong client contacts and relationships.</li>
<li>Responsible for entire data management process from study set-up to study close-out; primary contact on all data management study-specific issues; has high-level knowledge of drug development as it pertains to data management.</li>
<li>Actively participates in protocol review with clients, providing suggestions regarding ability to capture protocol information in database successfully.</li>
<li>Strong understanding of GCP/ ICH guidelines and FDA regulations, as applicable to data management.</li>
<li>Creates training exercises; serves as mentor and trains new clinical data managers.</li>
<li>Provides oversight and resolves all issues in data management study processing activities including CRF tracking and data entry, integration of external electronic data (e.g., lab data) with clinical database, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits.</li>
<li>Oversees and develops data management study documentation including Case Report Forms, CRF Completion Guidelines, Database Design via annotated CRFs, Validation specifications (edit checks), and Data Management Plan.</li>
<li>Preparation of any study tracking and metric reports for use by the study team.</li>
<li>Oversees execution of user acceptance testing (UAT) of study-specific systems and applications.</li>
<li>Interacts with cross-functional team members to ensure completion of all timelines and studies.</li>
<li>Participates in data management and/or organizational initiatives.</li>
<li>Initiates SOP updates and provide specifications for DM systems/ tools and process enhancements.</li>
<li>May act as resource for QC activities in collaboration with QC Coordinator.</li>
<li>Understands and follows processes related to project management as appropriate for data management projects (e.g., updating PSS, close-out procedures, etc.).</li>
<li>Confident, positive attitude displayed towards clients and projects.</li>
<li>Willingness to learn new skills and expand knowledge of drug development.</li>
<li>Leads data management projects with little management oversight.</li>
<li>Ability to work independently and resolve issues.</li>
<li>Ability to clearly articulate the DM services offered at company, including pros and cons of various DM approaches (specific to a client or operating model). To include potential attendance at (web or remote) capabilities and bid defense meetings.</li>
</ul>
Requirements:
<ul>
<li>Bachelor’s or Master’s Degree in scientific or health care field preferred with industry or relevant experience.</li>
<li>5+ years’ experience in data management field with a minimum of 1 year of experience leading projects.</li>
<li>Extensive knowledge of paper CRF study systems, EDC, and hybrid CDM systems.</li>
<li>Extensive knowledge of Clinical Operations SOPs and Working Practices.</li>
<li>Excellent verbal and written communication skills, as well as, interpersonal and organizational skills.</li>
</ul>
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