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Bristol Myers Squibb Manager, External Clinical Trial Data Acquisition in Berkeley Heights, New Jersey

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.

Responsibilities:

  • Developing the data collection strategy for external vendor/partner generated clinical trial data, championing consistency across programs and therapeutic areas.

  • Serving as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level, managing the completion of study start up, amendment and post final changes.

  • Creating external data transfer specifications, ensuring external clinical trial 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. Seeking support from leadership as needed.

  • Following procedural documents when completing deliverables.

  • Actively participating in continuous improvement activities, defining and implementing the changes required to create industry-leading capabilities.

  • Supporting preparations and follow-up actions related to Health Authority inspections and internal audits.

  • Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of BMS.

  • Developing strong and productive working relationships with key stakeholders throughout GDMCM, GDO, and BMS.

  • Representing the Company in interactions with key external partners as part of any committee or industry group.

Requirements:

  • Bachelors degree required with scientific or data integration disciplines preferred.

  • At least 4 years of global clinical trial expertise with a focus on external clinical data acquisition or equivalent scientific experience within the biopharmaceutical industry.

  • Good understanding of the drug development process and clinical trial start-up/execution. Proven expertise in external data acquisition processes and technologies.

  • Solid knowledge of industry leading external data acquisition tools and well versed in industry trends and emerging technologies supporting data acquisition. · Strong knowledge of GCP/ICH guidelines.

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

  • Demonstrated partnership across various collaborative forums.

  • Demonstrated ability to self-start, be solution-oriented, collaborate effectively with other stakeholders, and be accountable for results.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Company: Bristol Myers Squibb

Req Number: R1546941

Updated: 2021-09-26 04:08:59.837 UTC

Location: Berkeley Heights,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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