Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll 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.

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. Read more: .

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.

Functional Area Description

CDM is responsible for integrity, reliability, completeness and quality of clinical trial data and provides end to end clinical data management leadership for trials across the BMS R&D portfolio.

Responsibilities will include, but are not limited to:

Program Management

• Act as a Program Lead to provide oversight of a program within the organization providing oversight to a group of studies and Data Management staff ensuring that the studies within the program are delivered per corporate goals and objectives

• Establish a governance framework for a program or asset to ensure monitoring of risks and mitigation strategies across different studies within the program

• Developing strong and productive working relationships with cross functional stakeholders responsible to provide strategic support to project team

• Responsible for attending program level strategic meetings

• May act as a driver to set program level data collection and review standards with cross functional team in partnership with global standards

Line Management

• Line management responsibility of Data Management staffbased on business requirements

• Manages the resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trials

• Forecast\xe2\x80\x99s future resource needs based on the book of work and initiatives; proposing solutions to meet potential resource constraints

• Assigns resources to initiatives in line with their development plans and providing appropriate guidance to staff to influence results and drive to completion

• Works proactively with staff to understand individual strengths, opportunities, and career goals; supporting development of plans that capitalize on strengths and address opportunities; providing regular feedback to promote development.

• Effectively coaches and mentors\xe2\x80\x99 staff, seeking out training opportunities where needed, to develop the next generation leaders.

• Develops and promotes a workplace culture that values diversity of thought, promotes integrity, creates accountability, supports effective decision making, and provides opportunities to grow.

Project Management and Leadership

• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects

• Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects

• Responsible for end-to-end clinical data management activities and may serves as a primary point of contact for internal and external study team members

• Provides strong quality and project oversight over third party vendor responsible for data management deliverables

• Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes

• May author, review/revise DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization

• Participate in Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness

• Represents DM on cross-functional project teams, portfolio review meetings & Submission Teams

• Lead or support the Health Authority inspections and audits

FSP/CRO/Vendor Oversight

• May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)

Continuous improvement initiatives

• Supports change management initiatives with broad impact as a lead or participant in initiatives, and/or authors (or participates in) functional SOPs/WP/GD

• Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality

• May mentor new or existing team members, as applicable

• Lead CAPA management activities and ensure timely closure of CAPA action items

• Holds accountability to resolve complex issues and proactively develop solutions, within the function and across functions. Leveraging technical/functional expertise to develop solutions. Using clear communications and collaborative strategies to drive to resolution

• Authors procedural documents (SOPs, work instructions, job aids) and coordinating reviews/approvals. Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained.

#HYDDD

#LI-Hybrid

If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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.

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

Bristol-Myers Squibb