Clinical Data Manager I

Now Hiring: Clinical Data Manager | Clinical Development ** Primarily remote

but must be

available to travel to Boston

as needed to support face to face meetings and during user acceptance testing. **

We are seeking an experienced and highly motivated

Clinical Data Manager (CDM)

to support an expanding clinical trial portfolio within a fast-paced and collaborative clinical development environment. This is an exciting opportunity to contribute to innovative clinical programs while working cross-functionally with Clinical Operations, Biometrics, Medical Affairs, Regulatory, Safety, and external CRO partners. The ideal candidate will bring strong clinical data management expertise, vendor oversight experience, and a passion for delivering high-quality clinical data in compliance with global regulatory standards.

Position Overview The Clinical Data Manager will support all aspects of clinical data management activities across multiple clinical studies while ensuring data quality, integrity, and compliance with applicable regulatory requirements, GCP guidelines, and internal SOPs. This role will report directly to the

Manager, Clinical Data Management

and will play a critical role in database development, data review, vendor oversight, reconciliation activities, and study support through database lock.

Key Responsibilities Support development and management of clinical databases including: User requirements eCRFs Edit checks and validation rules User Acceptance Testing (UAT) Assist in developing and maintaining key data management documents including: Data Management Plans (DMPs) CRF Completion Guidelines Data validation specifications Manual review guidelines Collaborate with internal study teams and CRO partners to ensure all data management deliverables and timelines are achieved Support implementation and oversight of study systems including: EDC ePRO/eCOA IRT systems Oversee and support data cleaning activities and reconciliation of external data sources including laboratory, ECG, and ePRO data Review study data regularly throughout study conduct to support database lock activities Develop and maintain oversight listings, reports, programming checks, and patient profiles with Biometrics teams Maintain internal Data Review Logs and coordinate issue resolution with vendors Review CRO metrics, reconciliation logs, and quality reports to ensure timely issue escalation and resolution Troubleshoot and resolve data-related issues proactively Support audits, inspections, TMF/eTMF review activities, study kickoff meetings, and investigator meetings as needed Maintain meeting minutes and decision logs for internal data management activities

Required Qualifications Bachelor’s degree in a science-related field, computer systems, IT, or related discipline 3–4 years

of clinical research and clinical data management experience within Sponsor, CRO, or site environments Experience with EDC systems such as: Medidata RAVE Medrio Oracle Veeva CDMS Strong vendor oversight and CRO management experience Experience with electronic Trial Master Files (eTMF) Strong understanding of: GCP Clinical trial processes FDA, EMA, PMDA, and global regulatory requirements Familiarity with: CDISC/CDASH SDTM MedDRA WHODrug dictionaries Strong organizational, project management, and multitasking abilities Excellent verbal and written communication skills Strong proficiency with Microsoft Office applications including Excel, Word, and PowerPoint Critical thinking and problem-solving capabilities with strong attention to detail

Preferred Qualifications Familiarity with Pinnacle 21 Experience with eCOA/ePRO and IRT systems Experience supporting audits and regulatory inspections Experience collaborating with cross-functional Biometrics and Programming teams

Why Join This Opportunity? Support innovative and expanding clinical development programs Gain broad exposure across clinical systems, vendor oversight, and global trial operations Collaborate with multidisciplinary teams in a highly dynamic environment Opportunity to contribute to impactful clinical research programs and process improvements

Interested or know someone who may be a fit? Apply today