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Clinical Trial Project Manager

5-8 years
Not Disclosed
10 Feb. 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Clinical Trial Project Manager

Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time Regular
Job ID: R-79410


About Eli Lilly:

Eli Lilly is a global leader in healthcare, driven by a passion for discovery and delivering life-changing medicines. With over 39,000 employees worldwide, the company strives to improve the understanding and management of diseases. The Clinical Trial Project Manager (CTPM) role is an essential position within Lilly's clinical trial operations, supporting efforts to bring new treatments to patients.


Position Overview:

The Clinical Trial Project Manager (CTPM) Associate will lead the cross-functional study team responsible for the development and execution of clinical trials. The role includes delivering trials on time, within scope, and within budget. The CTPM Associate will apply project management skills, clinical trial expertise, and scientific knowledge to coordinate global and regional activities to achieve trial deliverables.


Key Responsibilities:

  1. Project Management and Operational Oversight:

    • Develop and execute local, regional, and global clinical trials.

    • Manage trial scope, timelines, risks, and budgets using project management tools and processes.

    • Ensure alignment across teams to meet trial milestones and deliverables.

  2. Leadership in Clinical Trial Execution:

    • Coordinate cross-functional study teams and facilitate study implementation, execution, and closure.

    • Lead the trial enrollment strategy and manage country allocation through last patient entry.

    • Monitor risks and develop mitigation plans in collaboration with team members.

  3. Stakeholder and Vendor Management:

    • Serve as the primary point of contact for clinical development teams, third-party organizations (TPOs), and affiliates.

    • Build and maintain strong relationships with vendors and stakeholders to ensure smooth communication and resolution of issues.

  4. Process Leadership and Expertise:

    • Demonstrate expertise in the drug development process and clinical trial execution.

    • Ensure compliance with regulatory requirements, GCP, and Lilly’s standards.

    • Identify opportunities for continuous improvement within clinical trial processes and operations.

  5. Scientific Expertise and Consultation:

    • Provide scientific and regulatory consultation for clinical and regulatory documents.

    • Leverage scientific knowledge to support trial design, feasibility, and implementation.

    • Collaborate with internal and external partners to address trial needs.

  6. Problem-Solving and Decision-Making:

    • Apply critical thinking and problem-solving skills to manage trial-related challenges.

    • Ensure effective issue resolution and keep trial processes on track.


Minimum Qualifications:

  • Education: Bachelor's degree (scientific or health-related field preferred) or advanced degree.

  • Skills & Experience:

    • Applied knowledge of project management methodologies, tools, and techniques.

    • Experience working in cross-functional and cross-cultural teams, especially in global clinical trials.

    • Strong leadership and communication skills with the ability to influence without authority.

    • Ability to manage complex situations and navigate ambiguity with critical thinking.

    • Proficiency in project management tools (e.g., MS Project, MS Excel, MS PowerPoint).

    • Clinical trial experience and understanding of clinical research processes.


Additional Preferences:

  • Prior experience in clinical trial site management or affiliate operations.

  • Proficiency in project management tools and methodologies.

  • Willingness to travel periodically for the role.


Lilly's Commitment to Inclusion:

Lilly is committed to ensuring equal opportunities for all individuals, including those with disabilities. If you require accommodation to apply for a position, please complete the accommodation request form for assistance.


How to Apply:

To learn more and apply for the position, visit the Eli Lilly Careers page.