Senior Manager, External Data Setup Manager (eDSM)
The Senior Manager, Clinical Data Acquisition & Standards (External Data Setup Manager) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director, Clinical Data Acquisition & Standards (External Data Setup) within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Clinical Operations (GCO).
This is a full-time, office-based position located in Central New Jersey, USA or Belgium.
Driving the data collection strategy for vendor generated test results, championing consistency across programs and therapeutic areas.
Serving as the subject matter expert for the setup of external vendors at the study level, managing the completion of study start up, amendment and post final changes.
Creating data transfer specifications, ensuring vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting.
Working with Clinical Data Management to develop appropriate content and timelines for development and deployment of study databases.
Identifying and resolving issues which may negatively impact study deliverables. Escalating issues to leadership as needed.
Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.
Contributing to the development and application of smart systems and optimal approaches to support the collection of data.
Actively participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.
Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services on behalf of BMS.
Developing strong and productive working relationships with key stakeholders throughout GDMCM, GCO, 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.
Experience and Expertise Required:
Bachelor's degree required with scientific or data integration disciplines preferred.
At least 5 years of relevant industry experience with Data Management experience preferred.
Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.
Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena.
Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
Strong knowledge of GCP/ICH guidelines.
Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.
Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.