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Salary: USD 129,000 - 184,000 / annual
Relay Therapeutics, a clinical-stage precision medicines company, is seeking a Senior Manager of Clinical Data Management to join their growing team. You will report to the Director of Clinical Data Management and play an integral role in ensuring the delivery, integrity, and quality of clinical data analyses across Relay's clinical studies.
Key Responsibilities:
- Oversee and execute data management activities for assigned clinical studies, including timelines and key deliverables
- Work directly with and oversee CROs and vendors for outsourced data management activities; manage CRO performance and data management metrics
- Lead database development, eCRF design, UAT, data import specifications, and related operational manuals
- Lead data validation specifications to ensure accuracy of clinical trial data, including manual review guidelines, computerized edit check programs, and Data Management Plans
- Execute or oversee data cleaning activities through database lock, including generating and managing clinical trial data queries, data review listings, coding of clinical trial data (adverse events, concomitant medications), and reconciliation of serious adverse events and central labs
- Function as support to the lead data manager and provide technical and business expertise
- Lead and collaborate with study team members on data cleaning activities and oversee CRO data cleaning and database lock activities
- Review, maintain, and perform completeness QCs of study eTMF for Data Management documentation
- Oversee and participate in RAVE user access QCs
- Collaborate with cross-functional teams to ensure timeliness and quality of data deliverables
- Participate in and represent Data Management at study team meetings as needed
- Ensure compliance with global regulatory requirements and quality standards
Requirements:
- 7+ years of experience in pharmaceutical/biotechnology and/or CRO industry as a Lead Data Manager or Data Manager (sponsor experience preferred)
- Data cleaning experience in Oncology studies preferred
- Experience with Medidata Rave
- Advanced experience with data collection and cleaning covering Phase I/II/III studies and Healthy Volunteer studies
- Experience in CRO and vendor oversight
- Experience in integration of external vendor systems with EDC (Rave)
- Advanced Excel skills required
- Familiarity with industry standard data cleaning tools
- Strong problem-solving abilities with excellent communication and public speaking skills
- Strong interpersonal and organizational skills with high attention to detail
- Ability to manage multiple projects and priorities effectively in a fast-paced environment
