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Senior Manager, Line Manager-Clinical Data Management

4 months ago

Hyderabad, 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.
Responsibilities will include, but are not limited to:
Line Management
• Line management responsibility of Data Management Data Review staff based on business requirements
• Manages the resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trials
• Forecast’s 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’ 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.
Oversight for Clinical Data Review Team
•Responsible for managing and leading clinical data review team focusing on development, accountability, and success of team members.
•Leverages interpersonal and influencing skills to foster partnerships across global and/or multidisciplinary teams.
•Contributes to resource allocation decisions, considering strategy to ensure best fits for work assignment.
•Shares lessons learned relative to people management or process.
•Act as key point of contact for all clinical data review activities during study start up, conduct and closeout phases.
Contribute to the clinical data review and overall CDM process optimization and improvement
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 (primarily clinical data review tasks), 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.
Bachelor’s Degree required with an advanced degree preferred.
Minimal 6 years of relevant industry experience with strong line management expereince. Project management certification (e.g. PMP) is desirable. Strong experience in program governance in all phases of clinical trials for Clinical Data Management delivery. Strong experience in managing Clinical Data Review teams across therapeutic areas.
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
• Sound knowledge of Clinical Drug Development Process, regulatory and ICH guidelines (e.g. EMEA, FDA) and industry standard practices regarding data management
• Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
• Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
• Excellent oral and written communication skills
• Communicate effectively with senior management and cross-functional teams
• Solid knowledge of submission requirements, (e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA))
• Solution oriented mindset and ability to drive change.
•Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
•Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
•Ability to sustain high levels of performance in a constantly changing environment.
Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)
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
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.