Senior Manager, Line Manager-Clinical Data Management

6+ years

Not Disclosed

Hyderabad

10 Feb. 18, 2025

Job Description

Job Type: Full Time Education: PhD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Manager, Line Manager-Clinical Data Management
Hyderabad - TS - IN

Job Description
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.

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: careers.bms.com/working-with-us.

Responsibilities include, but are not limited to:

Line Management

Line management responsibility of Data Management Data Review staff based on business requirements.
Manages resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trials.
Forecasts 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 completion.
Works proactively with staff to understand individual strengths, opportunities, and career goals; supports development of plans that capitalize on strengths and address opportunities; provides regular feedback to promote development.
Coaches and mentors staff, seeking out training opportunities where needed, to develop the next generation of 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 the clinical data review team, focusing on the 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.
Acts as key point of contact for all clinical data review activities during study start-up, conduct, and closeout phases.
Contributes to clinical data review and overall CDM process optimization and improvement.

FSP/CRO/Vendor Oversight

May act as a 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.
Leads CAPA management activities and ensures 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.
Authors procedural documents (SOPs, work instructions, job aids) and coordinates reviews/approvals. Ensuring procedural documents are reflective of industry standards and regulatory requirements.

Qualifications

Bachelor's Degree required, with an advanced degree preferred.
Minimal 6 years of relevant industry experience with strong line management experience. 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.
Ability 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.
Solid knowledge of submission requirements (e.g., NDA/BLA/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 environments.

Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed)

5-10%

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
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 assigned is determined by the nature and responsibilities of the role.

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.

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.

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents.

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

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Senior Manager, Line Manager-Clinical Data Management

Job Description

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