Senior External Data Setup Manager, External Data Setup

Clinical Dev

icon-location-marker Braine L'Alleud - BE
icon-location-marker Celgene - Berkeley Heights - NJ
Posted 2 days ago Full_time R1518891

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary

The Senior External Data Setup Manger is a role with oversight of the external vendor data start up activities and directly contributes to the BMS R&D pipeline.

Role Responsibilities

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.

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 and/or leading 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, 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.

Qualifications

Bachelor’s degree required with scientific or data integration disciplines preferred.  At least 5 years of relevant industry experience with Data Management experience preferred.

Key Competency Requirements

Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices.

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.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.