Bristol Myers Squibb Senior Manager, EDC Database Development 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.
The Senior Manager, EDC Database Development, Clinical Data Acquisition & Standards is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director – EDC Database Development, Clinical Data Acquisition & Standards 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 New Jersey.
Building, maintaining, and deploying study databases to collect clinical trial data, including configuring custom integrations.
Managing work assignments to ensure timely delivery of study databases.
Working with Data Management to develop appropriate timelines for development and deployment of study databases.
Identifying and resolving issues which may negatively impact delivery of study databases. 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. Function Service Providers, CROs, technology providers, etc.) performing database development 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 relating to database development.
Some Senior Managers may also be responsible for managing Functional Service Providers - Reviewing deliverables and timelines, providing ongoing feedback and performance review, empowering and holding staff to high quality performance and delivery.
Education and Experience Required
Bachelor’s degree required with an advanced degree preferred. At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.
At least 5 years of database development experience in Rave.
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.
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
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.
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1543806
Updated: 2021-08-02 06:51:46.488 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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