Role Summary
Reporting to the Associate Director of Clinical Data Management, the Senior Manager of Clinical Data Management will be responsible for managing clinical data management activities across TangoβΓΓ΄s clinical trials. This includes overseeing study-specific data management processes from trial planning through database lock. This role involves collaborating with cross-functional teams and external partners to ensure high-quality, timely clinical data, supporting the operational execution of clinical trials.
Responsibilities
- Serve as the lead data management representative on cross-functional study teams
- Manage day-to-day clinical data management activities with CROs and vendors to ensure timely and accurate data capture
- Develop, review, and maintain study-specific data management documentation, including Data Management Plans (DMPs), CRF Completion Guidelines, and Data Review Guidelines
- Provide leadership and oversight for user acceptance testing (UAT) of eCRFs and associated edit checks
- Guide and monitor data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders
- Establish, review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets
- Partner with CROs to manage timelines and deliverables for data management activities
- Contribute to database lock activities, ensuring audit readiness and data integrity
- Maintain and ensure accuracy of study-specific trackers and metrics dashboards
- Create and manage data deliverable timelines and tasks
- Review and provide feedback on vendor data transfer agreements, transfers and reconciliation
Qualifications
- BS with 5+ years of clinical data management experience in CRO, pharma, or biotech settings
- Strong experience with Medidata Rave EDC systems and electronic trial master files (eTMF)
- Demonstrated knowledge of ICH/GCP, FDA regulations, and clinical trial processes
- Proficiency in industry data standards including CDISC, SDTM, and CDASH
- Prior experience collaborating with CROs on clinical studies
- Highly organized with excellent communication and interpersonal skills
- Experience in small biotech environments highly preferred
- Familiarity with data visualization or analytics tools such as R, SAS or elluminate
- Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
- Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
- Ability to manage multiple projects in a fast-paced environment
Skills
- Clinical data management leadership
- Data quality management
- Vendor and CRO coordination
- eCRF/UAT oversight
- Data standards (CDISC, SDTM, CDASH)
- Medidata Rave and eTMF proficiency
- Project management
Education
Additional Requirements