Manager, EDC Database Developer

2 weeks ago

Hyderabad, Telangana, India Bristol Myers Squibb Full time

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.

Position Summary

The Manager, EDC Database Development, contributes directly to the success of the BMS R&D pipeline and 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 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 protocol review/understanding, initial study database development and changes required after initial deployment. Programming study eCRFs, edit checks and/or custom functions. Contributing to the development of appropriate timelines for development and deployment of study databases. Providing EDC technical expertise in 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. 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 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 GDM, GDO, and BMS. Representing the Company in interactions with key external partners as part of any committee or industry group.

Degree Requirements

Bachelor's degree required

Experience Requirements

At least 4 years of global clinical trial expertise with a focus on EDC database development. At least 3 years of hands-on clinical database development experience in Rave.

Key Competency Requirements

Good understanding of the drug development process with proven expertise in clinical trial start-up/execution and EDC database development. Solid 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. Good 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, WHO Drug). Experience with CDISC standards including CDASH and SDTM is desirable. Demonstrated partnership across various collaborative forums. Demonstrated ability to self-start, be solution-oriented, collaborate effectively with stakeholders, and be accountable for results.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through scienceTM ", 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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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