Senior Manager, Clinical Data Management
Relay Therapeutics•Cambridge, MA
•$129,000 - $184,000
About The Position
As Sr Manager, Clinical Data Management you will be an integral member of the team and play an instrumental role in delivery, integrity, and quality of Relay Tx’s clinical data analyses across the clinical studies. You will report to the Director, Clinical Data Management.
Requirements
- 7+ years of experience in the pharmaceutical/biotechnology and/or CRO industry as a Lead Data Manager or Data Manager (sponsor experience is preferred)
- Experience in 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
- Motivated self-starter who is capable of flourishing in a fast-paced small company environment
- Experience in integration of external vendor systems with EDC (Rave)
- Advanced skills in excel are required
- Creative problem-solver with excellent communication and public speaking skills
- Strong interpersonal and organizational skills, with a high degree of attention to detail
- Pragmatic and able to manage multiple projects and priorities effectively
- Familiar with industry standard data cleaning tools
Nice To Haves
- Data cleaning experience in Oncology studies is preferred
Responsibilities
- Oversight and execution of data management activities for assigned clinical studies including data timelines and key deliverables
- Work directly with and oversee CROs and vendors for outsourced Data Management activities and be responsible for CRO performance and data management metrics for assigned studies
- Lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals
- Lead data validation specifications for assuring the accuracy of clinical trial data, e.g., manual data review guidelines, computerized edit check programs, Data Management Plans (DMP).
- Responsible for executing or overseeing data cleaning activities through to database lock: includes generating and managing clinical trial data queries, data review listings, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events and central labs.
- Function as support to the lead data manager for a clinical study and provide technical and business expertise in support of data management activities
- Lead and collaborate with study team members on data cleaning activities and provide oversight of CRO data cleaning activities 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 a dynamic Relay cross-functional team to ensure timeliness and quality of data deliverables
- Participate and/or represent Data Management at study team meetings, as needed
- Ensure compliance with global regulatory requirements and quality standards
- Provide technical and business expertise in support of data management deliverables
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
