Senior Manager, Clinical Operations Manager

Bristol-Myers Squibb Co; Mumbai; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Bristol Myers Squibb in Mumbai is seeking an experienced Senior Manager for Clinical Operations to lead country-level trial execution, coordinate CTMs, CTAs and study start-up staff to ensure timely delivery aligned with R&D priorities.

You will drive resource planning, manage budgets and CAPA processes, and collaborate with cross-functional teams, while upholding ICH-GCP standards and local regulations. The role requires strong leadership, communication, and vendor/site relationship skills.

Qualifications

• In depth understanding of ICH-GCP, Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
• In depth knowledge and understanding of clinical research processes, regulations and methodology
• Strong organizational and planning skills with independent decision-making ability
• Outstanding interpersonal, oral and written communication skills to influence, inform or guide others

Responsibilities

• Supervises and coordinates the work assignments and performance of Clinical Operations staff to ensure timely execution
• Communicates with and influences individuals at all levels of the organization
• Anticipates resource needs and provides workload evaluations and task assignments
• Supervises clinical trial execution at country level including supervising study metrics and team performance
• Manages study budgets and approvals for study fee funds and payments
• Ensures CAPA implementation and necessary resources/tools are available
• Develops goals aligned with R&D and local research priorities and tracks performance metrics

Skills

ICH-GCP knowledge

Regulatory knowledge

Stakeholder management

Leadership

Education

Bachelor's degree in life sciences

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:

• Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial Monitors (CTMs), Clinical Trial Associates (CTAs), Study Start-up Specialists and/or Site Contract Leads to ensure timely execution, consistent with R&D and local research goals and priorities
• Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management
• Anticipates resource needs and provides workload evaluations and task assignments
• Allocates and assign study resources in alignment with R&D and local research goals and priorities
• Supervises clinical trial execution at country level including supervising study metrics and team performance
• Approves study fee funds and payments based on grant of authority
• May propose and/or validate country study targets
• May support Health Authority inspection and pre-inspection activities
• May support audit preparation & Corrective Action / Preventative Action preparation for local related issues
• Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available
• Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met
• Together with the RCO management tracks and manages performance metrics for Clinical Operations staff
• Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit
• Point of Contact for FSP staff within the country
• Managing the hiring, performance management and succession planning of staff
• Performing general and human resource administrative functions
• Participation in performance calibration and talent review meetings
• Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
• When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager
• Ensure effective external partnerships with Study Sites, Investigators, Pharma. Trade Associations, Ministry of Health and /or Heath Authorities as needed
• Manage partnerships with critical accounts / site

Qualification and experience:

Specific Knowledge, Skills, Abilities:

• In depth understanding of ICH-GCP, Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
• 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
• Outstanding interpersonal, oral and written communication skills to influence, inform or guide others
• Good verbal and written communication skills

Education/Experience/ Licenses/Certifications:

Bachelors required preferably within life sciences or equivalent 12-15 years of experience in clinical operations

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 [e-mail]. 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 [e-mail] 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.

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We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.