Clinical Data Manager I

Now Hiring: Clinical Data Manager | Clinical Development

Please ensure you read the below overview and requirements for this employment opportunity completely.
** 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 OverviewThe 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 ResponsibilitiesSupport development and management of clinical databases including:User requirementseCRFsEdit checks and validation rulesUser Acceptance Testing (UAT)Assist in developing and maintaining key data management documents including:Data Management Plans (DMPs)CRF Completion GuidelinesData validation specificationsManual review guidelinesCollaborate with internal study teams and CRO partners to ensure all data management deliverables and timelines are achievedSupport implementation and oversight of study systems including:EDCePRO/eCOAIRT systemsOversee and support data cleaning activities and reconciliation of external data sources including laboratory, ECG, and ePRO dataReview study data regularly throughout study conduct to support database lock activitiesDevelop and maintain oversight listings, reports, programming checks, and patient profiles with Biometrics teamsMaintain internal Data Review Logs and coordinate issue resolution with vendorsReview CRO metrics, reconciliation logs, and quality reports to ensure timely issue escalation and resolutionTroubleshoot and resolve data-related issues proactivelySupport audits, inspections, TMF/eTMF review activities, study kickoff meetings, and investigator meetings as neededMaintain meeting minutes and decision logs for internal data management activities
Required QualificationsBachelor’s degree in a science-related field, computer systems, IT, or related discipline3–4 years of clinical research and clinical data management experience within Sponsor, CRO, or site environmentsExperience with EDC systems such as:Medidata RAVEMedrioOracleVeeva CDMSStrong vendor oversight and CRO management experienceExperience with electronic Trial Master Files (eTMF)Strong understanding of:GCPClinical trial processesFDA, EMA, PMDA, and global regulatory requirements xzbcwsv Familiarity with:CDISC/CDASHSDTMMedDRAWHODrug dictionariesStrong organizational, project management, and multitasking abilitiesExcellent verbal and written communication skillsStrong proficiency with Microsoft Office applications including Excel, Word, and PowerPointCritical thinking and problem-solving capabilities with strong attention to detail
Preferred QualificationsFamiliarity with Pinnacle 21Experience with eCOA/ePRO and IRT systemsExperience supporting audits and regulatory inspectionsExperience collaborating with cross-functional Biometrics and Programming teams
Why Join This Opportunity?Support innovative and expanding clinical development programsGain broad exposure across clinical systems, vendor oversight, and global trial operationsCollaborate with multidisciplinary teams in a highly dynamic environmentOpportunity to contribute to impactful clinical research programs and process improvements
Interested or know someone who may be a fit? Apply today