Associate Manager, Clinical Data Management

Job Description

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Associate Manager, Clinical Data Management Responsibilities will include, but are not limited to: Study Startup: Draft EDC build timeline in collaboration with Data Management Lead. Perform DB build tasks by creating specifications for Database and Edit Checks. Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway. Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks. Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review. Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan. Study Conduct: Plan/execute Post Production/Migration for the study (if any). Coordinate with Clinical Data Managers for the execution of data review tasks. Coordidate with external data vendors for any escalations related to any vendor data. Support Clean Patient Group delivery along with Clinical Data Management staff. Update study documents as needed during the conduct of the study Support DML to coduct Data Quality Review meetings. Provide Data Health Metrics to Data Management Lead as requested. Study Closeout- Support Data Management Lead in planning and execution of database lock activities. Perform post lock activities, as needed. Project Management Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality. Documentation: Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship: Provide Training and mentoring to junior CDM staff. Bachelor s Degree required. Life sciences, Pharmacy or relevant fields preferred. 6 years of experience in managing end to end Clinical Data Management tasks. Able to work on end to end Clinical Data Management tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Strong project management skills