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Manager Global Clinical Operations

5+ years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: 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

Position: Manager, Global Clinical Operations
Function: R&D Operations
Sub-Function: Clinical Trial Project Management
Category: Manager, Clinical Trial Project Management (PL7)
Location: Mumbai, Maharashtra, India
Date Posted: Jan 27, 2025
Requisition Number: 2406227116W


Position Summary

The Manager, Clinical Operations is responsible for the operational management and successful execution of clinical trials in the assigned therapeutic area(s). This role involves overseeing resource allocation, timelines, budget adherence, compliance, and ensuring adherence to SOPs, HCC policies, and regulatory requirements.

The Manager, Clinical Operations also plays a critical role in line management of clinical operations staff, driving process improvements, mentoring talent, and ensuring clinical trial excellence at the country level.


Key Responsibilities

People & Resource Management

  • Provide line management for Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA), and other clinical operations staff.
  • Set performance goals, evaluate progress, and develop talent.
  • Forecast and allocate resources efficiently across projects.
  • Oversee the hiring and development of new talent.
  • Guide team members in issue resolution and stakeholder communication.

Clinical Trial Execution & Oversight

  • Ensure timely and high-quality execution of clinical trials across all phases (from feasibility to close-out).
  • Oversee feasibility assessments, site selection, and site readiness within assigned therapeutic areas.
  • Ensure inspection readiness and compliance with ICH-GCP, regulatory guidelines, and SOPs.
  • Implement the One Delivery Model and collaborate with vendors for operational excellence.

Leadership & Strategy

  • Drive organizational culture transformation to adapt to future innovations.
  • Lead organizational changes, manage priorities, and provide clear strategic direction.
  • Define and support long-term strategies in alignment with GCO, GD, and R&D objectives.
  • Foster an environment that encourages knowledge sharing and innovation.
  • Represent the company with health authorities, ethics committees, and investigational sites as needed.

Process Improvement & Compliance

  • Analyze operational and quality metrics to identify and implement process improvements.
  • Ensure compliance with budgeting, financial planning, and expense approvals.
  • Maintain a culture of continuous improvement in clinical operations.

Qualifications

Leadership & Organizational Influence: Ability to shape culture and drive innovation in clinical operations.
Mentorship & Coaching: Experience in mentoring, coaching, and team management.
Clinical Operations Expertise: Strong knowledge of clinical trial execution, regulatory requirements, and process optimization.
Financial & Decision-Making Skills: Proficient in budgeting, resource allocation, and decision-making.
Flexibility & Problem-Solving: Ability to adapt in a dynamic environment and resolve challenges proactively.
Strong Communication & Collaboration: Fluent in English with excellent interpersonal, negotiation, and organizational skills.
Technical Proficiency: Computer literacy and ability to manage projects in a matrix organization.


Why Join Us?

🚀 Work on cutting-edge clinical research that impacts global healthcare.
🌎 Be part of a diverse, global talent hub focused on bold innovations.
📈 Grow your career with leadership opportunities and strategic influence.
💡 Contribute to a mission of changing the trajectory of human health.


How to Apply

Join us in tackling the world’s toughest healthcare challenges. Apply now and become part of our Global Talent Hub!