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Manager, Clinical Data Operations
2 months ago
Bristol-Myers Squibb Company is seeking a highly skilled and experienced Manager, eCOA Management to join our team. As a key member of our Global Data Management department, you will play a critical role in the operationalization of electronic Clinical Outcome Assessment (eCOA) instruments for clinical trials.
Key Responsibilities- Provide leadership for the operationalization of eCOA instruments, facilitating the end-to-end process and working with clinical study teams and vendors to meet study requirements.
- Work with eCOA vendors to ensure eCOA development is planned and executed effectively, both for initial deployment and post-production updates, ensuring timely delivery and issue resolution.
- Collaborate with stakeholders to ensure contracts, licenses, and translations are executed for timely eCOA delivery.
- Review and coordinate study-level eCOA process documents with clinical study team members.
- Oversee eCOA development and testing activities, ensuring requirements are well-defined and met.
- Resolve eCOA issues during study conduct in collaboration with study team members and vendors.
- Ensure effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.
- Manage work assignments to ensure timely delivery.
- Identify and resolve issues that may negatively impact delivery of work, seeking support from leadership as needed.
- Follow procedural documents when completing deliverables.
- Participate in continuous improvement activities as required.
- Support preparations and follow-up actions related to Health Authority inspections and internal audits for assigned studies.
- Develop strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS.
- Bachelor's degree required.
- At least 4 years of relevant industry and clinical trial experience, including at least 3 years of specific experience with eCOA technologies, instruments, and end-to-end operationalization of eCOA.
- Good understanding of the drug development process with proven expertise in clinical trial start-up/execution and eCOA operationalization in a global arena.
- Solid technical expertise in eCOA processes, instruments, and clinical data acquisition/integration.
- Knowledge of industry-leading tools and emerging technologies supporting eCOA.
- Good knowledge of GCP/ICH guidelines.
- Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
- Demonstrated partnership across collaborative forums.
- Ability to self-start, be solution-oriented, collaborate effectively with stakeholders, and be accountable for results.
