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Associate Director, Clinical Data Management (Data Management Lead)

Employer
Bristol Myers Squibb Company
Location
Hopewell, NJ, United States
Start date
Aug 9, 2019

View more

Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

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.

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.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.

The Associate Director, Clinical Data Management (Data Management Lead) is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role can report to the Director, Clinical Data Management or Associate Director, Clinical Data Management (Line Manager) within the Global Data Management and Centralized Monitoring function of Global Clinical Operations (GCO).

Specifically, the Associate Director, Clinical Data Management (Data Management Lead) is accountable for:

Providing leadership of clinical data management activities across one or more complex clinical development programs enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.

A key role (Data Management Lead) that serves as the primary point of contact to the wider clinical trial team for clinical trial data related matters. The DML will, in turn, coordinate activities across clinical data management, clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting.

A consistent approach to the gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards, and also responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness at all times.

Leading activities with external vendors developing systems/applications for clinical trial data collection (e.g. ePRO/eCOA) to ensure quality and timely deployment.

Implementation of the Data Quality Management Plan (DQMP) defining and documenting the data quality review strategy for each clinical trial in collaboration with various BMS stakeholders (e.g. statistics, medical, safety, development, GCO, etc.), enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities.

Supporting clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs/ePROs/eCOAs.

Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing data management services on behalf of BMS.

Contributing to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.

Participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to data management.

Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Experience and expertise required

Bachelor's degree required with an advanced degree preferred. At least 7 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.

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.

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.

A good understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

Experience in data management and well versed in industry trends and emerging industry dynamics concerning data review.

A good understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.

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.).

Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.

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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