Senior Manager, EDC Database Development
- Employer
- Bristol Myers Squibb Company
- Location
- Celgene, NJ, United States
- Start date
- Sep 2, 2020
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- Discipline
- Information Technology, Database Administration
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
The Senior EDC Database Developer 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 Line Manager within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Development Operations (GDO).
This is a full-time, office-based position located in Central New Jersey, USA.
Responsibilities Include
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, 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 relating to database development.
Some Senior Database Developers may also be responsible for mentoring/managing Functional Service Providers - Reviewing deliverables and timelines and holding staff to high quality performance and delivery.
Experience and Expertise Required
Bachelor's degree required with an advanced degree preferred. At least 5 years of relevant industry experience.
Strong project management skills: Project management certification (e.g. PMP) is desirable.
At least 5 years of database development experience in Rave.
Strong knowledge of clinical study design.
Experience with CDISC standards including CDASH and SDTM 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.
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.
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.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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