Senior Manager – Ecoa Management
| Company | Bristol Myers Squibb |
|---|---|
| Location | Summit, NJ, USA, Princeton, NJ, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree required
- At least 5 years of relevant industry and clinical trial experience including specific experience with eCOA technologies and instruments and end to end operationalization of eCOA
- Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and end to end eCOA operationalization in a global arena
- Strong technical expertise in the area of eCOA processes, instruments, and clinical data acquisition/integration
- Strong knowledge of industry leading tools and well versed in industry trends and emerging technologies supporting eCOA
- Strong knowledge of GCP/ICH guidelines
- Proven experience with reviewing technical documents, writing documents, and applying Systems Development LifeCycle (SDLC) and system validation principles
- Demonstrated partnership across various collaborative forums and with external partners
- Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)
- Demonstrated ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results
Responsibilities
- Providing leadership for the operationalization of eCOA instruments for clinical trials, facilitating the end to end process, providing expertise to clinical study teams and working with them and vendors to implement eCOA to meet study requirements
- Working with eCOA vendors to ensure eCOA development is planned effectively and executed according to plan, both for initial eCOA deployment and post production updates
- Working with other stakeholders to ensure contracts, licenses and translations are executed to enable timely eCOA delivery
- Reviewing documents required for the study level eCOA process and coordinating reviews with study team members as needed
- Overseeing eCOA development and testing activities, ensuring requirements are well defined and met
- Working with study team members and vendors to ensure eCOA issues during study conduct are effectively resolved
- Ensuring effective quality oversight and management of external partners performing eCOA activities on behalf of BMS
- Managing work assignments to ensure timely delivery
- Identifying and resolving issues which may negatively impact operationalization of eCOA tools, using collaborative strategies to reach resolution
- Escalating issues to leadership appropriately
- Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes
- Training and/or mentoring newer team members on key activities and processes
- Actively participating in and/or leading continuous improvement activities
- Supporting preparations and follow-up actions related to Health Authority inspections and internal audits
- Developing strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management
- Representing the Company in interactions with key external partners as part of any committee or industry group relating to database development
Preferred Qualifications
-
No preferred qualifications provided.