Senior Manager, EDC Database Development

Bristol-Myers Squibb Company

Ts, IN

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Job Title: Senior Manager, EDC (Electronic Data Capture) Database Development
Division: Research and Development (R&D), Global Development Operations (GDO), Global Data Management and Centralized Monitoring (GDM&CM)
Functional Area Description: GDM&CM is responsible for clinical trial data acquisition, data standards governance, data management, medical coding, data reporting and analytics, and centralized monitoring for trials across the BMS R&D portfolio.
Position Summary:The Senior Manager, EDC Database Development contributes directly to the success of the BMS R&D pipeline is responsible for the effective development of study level EDC databases. This is an individual contributor role.
This role reports to the Associate Director, EDC Database Development within GDM&CM and is a full-time, office-based position.

Position Responsibilities
•Building, maintaining and deploying study databases to collect clinical trial data, including configuring study database internal module connections and external system integrations. Being responsible for initial study database development and changes required after initial deployment. Taking responsibility for more complex studies in the portfolio which may require additional expertise.
•Contributing to the development of appropriate timelines for development and deployment of study databases.
•Providing EDC technical expertise to Data Management and to the clinical study team members to support study decisions.
•Managing work assignments to ensure timely delivery.
•Identifying and resolving issues which may negatively impact delivery of work, using collaborative strategies to reach resolution. Escalating issues to leadership appropriately.
•Following procedural documents and participating in reviewing and updating of documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
•Training and/or mentoring newer EDC Database Development team members on key activities and processes.
•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.
•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. Function Service Providers, CROs, technology providers, etc.) performing activities 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 global library develompent.

Degree Requirements: Bachelors degree required

Experience Requirements
•At least 5 years of global clinical trial expertise with a focus on EDC database development.
•At least 5 years of clinical database development experience in Rave.
Key Competency Requirements
•Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and EDC database development.
•Strong knowledge of industry leading EDC tools (e.g. Medidata Rave, Oracle/Inform, etc.) and well versed in industry trends and emerging technologies supporting data collection.
•Strong knowledge of clinical study design.
•Strong knowledge of GCP/ICH guidelines.
•Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
•Understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
•Experience with CDISC standards including CDASH and SDTM is desirable.
•Demonstrated partnership across various collaborative forums.
•Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
•Demonstrated ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results.

#HYDDD #LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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