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Clinical Trial Project Manager

0-2 years
Not Disclosed
10 Feb. 18, 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 (CTPM) Associate

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


About Eli Lilly and Company:

At Eli Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader, our mission is to deliver life-changing medicines and enhance disease management. We are committed to providing opportunities for passionate individuals to contribute to this mission.


Job Description:

Purpose:

The Clinical Trial Project Manager (CTPM) Associate leads the cross-functional study team to develop and execute clinical trials. This role is accountable for delivering trials with quality, on time, within scope, and within budget, both regionally and globally. The CTPM Associate brings expertise in project management, clinical trial processes, and scientific knowledge to drive successful clinical trial execution.


Primary Responsibilities:

  1. Project Management & Regional Operational Knowledge:

    • Develop and execute clinical trials using project management skills, processes, and tools.

    • Monitor project scope, timeline, budget, and risks.

    • Collaborate with cross-functional teams to align on trial deliverables.

    • Oversee trial-level budget components, ensuring financial tracking.

    • Coordinate site and investigator training, managing relationships with third-party organizations (TPOs).

  2. Clinical Trial Process Leadership:

    • Lead clinical trial processes with a strong understanding of the drug development lifecycle.

    • Coordinate with affiliates, regulators, and cross-functional teams to ensure smooth trial execution.

    • Maintain inspection readiness for Trial Master File (TMF) records.

    • Address trial issues proactively, reducing or mitigating risks.

  3. Scientific Expertise:

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

    • Leverage scientific and operational knowledge to contribute to clinical trial design, feasibility, and implementation.

    • Ensure adherence to global/regional regulations and Good Clinical Practice (GCP).


Minimum Qualifications:

  • Education: Bachelor’s or advanced degree in a scientific or health-related field.

  • Experience: Applied knowledge of project management methodology and clinical trial processes.

  • Skills:

    • Ability to influence without authority and manage complex situations.

    • Strong leadership and networking skills.

    • Effective communication and organizational skills.

    • Proficiency in project management tools like MS Project, MS Excel, MS PowerPoint.


Additional Preferences:

  • Clinical trial experience with knowledge of the clinical research process.

  • Prior experience at clinical trial sites or affiliate levels.

  • Willingness to travel periodically.


Other Information:

Eli Lilly is committed to helping individuals with disabilities participate actively in the workforce. If you require accommodations to submit a resume, please complete the accommodation request form on our website.