Job Description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.


Key Responsibilities:

  • Oversees and collaborates with study team members and cross-functional stakeholders, to proactively identify opportunities and manage and mitigate risks and to ensure timely and on-budget execution of clinical trial deliverables.
  • Supports internal audit and inspection activities and contributes to corrective and preventive actions (CAPAs), including leading the resolution of issues when appropriate.
  • Monitors updates throughout a study’s lifecycle for compliance with regulations and standard operating procedures (SOPs), including contract research associate (CRA) compliance with study parameters and tracks escalation and closure of action items noted in monitoring visit reports during late phase studies including registration of protocols.
  • Monitors progress of clinical trials and identifies and resolves any issues or risks that may impact timelines or study outcomes.
  • Serves as the key operational contact for clinical studies, providing oversight for the site evaluation, initiation and close-out visits in addition to routine monitoring visits.
  • Participates in contract research organization (CRO) and vendor selection and manages all interactions and deliverables from relevant CROs and vendors under the guidance of leadership.

Qualifications and Experience Requirements:


  • Bachelors or Masters degree required.  Field of study within life sciences or equivalent
  • Clinical Trial Manager: Minimum of 4 years' industry related experience.
  • Senior Clinical Trial Manager: At least 6 years of industry related experience.
  • Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives.
  • Thorough understanding of GCP, ICH Guidelines and Country regulatory environment.
  • In depth knowledge and understanding of clinical research processes, regulations and methodology.
  • Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management.
  • Demonstrated organizational and planning skills and independent decision-making ability.
  • Strong organization and time management skills and ability to effectively manage multiple competing priorities.
  • Ability of critical thinking and risk analysis.
  • Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels.
  • Skilled in the use of technology.
  • Good verbal and written communication skills (both in English and local language).


We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.


Supporting People with Disabilities

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.


Candidate Rights

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


For roles based in Los Angeles County only:  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/


Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.


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

If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.



R1606706 : Senior Clinical Trial Manager


Job Details

Role Level: Mid-Level Work Type: Full-Time
Country: India City: Mumbai ,Maharashtra
Company Website: http://www.bms.com Job Function: Clinical & Lab Research
Company Industry/
Sector:
Pharmaceutical Manufacturing

What We Offer


About the Company

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