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Senior Manager, External Data Setup Manager (eDSM)

Employer
Bristol Myers Squibb Company
Location
Hopewell, NJ
Start date
Nov 6, 2019

Job Details

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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.

Responsibilities Include

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.

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 the resources to pursue their goals, both at work and in their personal lives.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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