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Rapport Therapeutics · 8 hours ago

Senior Manager, Clinical Data Management

United States

Full-time

Remote

Senior Level, Lead/Staff

$165K/yr - $185K/yr

8+ years exp

Rapport Therapeutics is focused on developing precision neuromedicines to improve patients' lives. As a Senior Manager in Clinical Data Management, you will lead clinical trials, oversee data management activities, and collaborate with CRO partners to ensure data accuracy and compliance with industry standards.

BiotechnologyHealth CareLife ScienceMedicalNeurosciencePrecision Medicine

Responsibilities

Serve as Data Management Lead on assigned clinical trials, attending CST meetings and overseeing all data management activities and timelines

Provide oversight of CROs, ensuring deliverables meet CDASH, SDTM, and industry standards

Review and approve database designs, edit checks, CRF Completion Guidelines, and Data Management Plans

Collaborate with programmers to design eCRFs and edit checks in the EDC system

Develop and execute User Acceptance Testing (UAT) scripts and test cases

Manage data imports, integration, reconciliation, and query resolution to ensure data accuracy and integrity

Perform routine data reviews and support medical coding validation with clinical teams

Assist in designing data listings and performing SAE reconciliation

Lead database cleaning, pre-lock, and lock activities

Create training materials and user guides for EDC systems

Generate and review study metrics and data status reports

Participate in team and client meetings, providing regular status updates

Archive study databases and documentation per regulatory and company standards

Support timeline planning and implement technical solutions as needed

Qualification

Clinical Data ManagementEDC PlatformsCDASHSDTMData Validation GuidelinesUser Acceptance TestingData Visualization ToolsRegulatory KnowledgeCommunicationTime ManagementCross Collaboration

Required

Bachelor's Degree in a scientific or health related field or equivalent

8+ years of clinical data management experience in biotech or pharma

Experience across EDC platforms, Medidata EDC preferred

Proven ability to represent Data Management on cross-functional Clinical Study Teams (CST)

Industry or sponsor-side experience in a clinical research environment required

Solid technical skills across data platforms

Leading a trial from a Data Management perspective

Previous experience designing clinical trials utilizing CDASH and SDTM standard terminology

Proficient in cross collaboration with other related functions such as Biostatistics, Statistical Programming, Clinical Operations and Pharmacovigilance

Ability to manage multiple projects in a fast-paced environment

Excellent communication and time management skills