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