Associate Director - Clinical Research Lead

10+ years

Not Disclosed

Gurgaon

10 Dec. 17, 2024

Job Description

Job Type: Full Time Part 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 Development Consultant (CRL)
Location: Global (Travel Required 50-75%)
Job Type: Full-time

Job Summary:
At Lilly, we unite caring with discovery to make life better for people around the world. We are seeking a Clinical Development Consultant (CRL) to join our team, responsible for managing clinical sites involved in Lilly clinical trials. The CRL will ensure site identification, enrollment, and timely delivery of clinical trials, supporting global program delivery while maintaining high-quality interactions with clinical trial sites to drive exceptional customer experiences. This role also includes oversight of vendor monitoring activities, risk management, and ensuring inspection readiness.

Responsibilities:

Clinical Investigator Management:

Oversee site activities from identification, qualification, enrollment, database lock, and close-out.
Manage performance and resolve issues related to site recruitment and enrollment.
Build strategic relationships with clinical investigators to ensure the successful delivery of clinical trials.
Apply scientific, therapeutic area, and regional expertise to ensure timely delivery of trial enrollment and data quality.

Clinical Trial Management:

Develop and implement site risk management plans to meet enrollment commitments and database locks.
Ensure constant inspection readiness at the site and country level.
Collaborate with teams to remove barriers and ensure successful trial execution.
Understand local treatment paradigms and use this knowledge to support trial feasibility and site allocation.
Provide oversight of vendor monitoring activities at site/country levels.

Business Management and Engagement:

Establish and maintain professional relationships with clinical investigators and potential sites to enhance clinical trial opportunities.
Collaborate cross-functionally to align priorities and deliver the portfolio.
Conduct site prospecting aligned with the clinical trial strategy and portfolio needs.
Act as the communication bridge between sites, third-party vendors, and Lilly, ensuring smooth operation.

Qualifications:

Bachelor’s degree or equivalent in a scientific or health-related field.
Minimum 8-10 years of experience in the pharmaceutical industry and/or clinical research, with strong knowledge of Good Clinical Practice (GCP).
Therapeutic expertise and understanding of the clinical research landscape.
Strong self-management, organizational, and leadership skills.
Ability to influence and challenge internal and external stakeholders.
Strong decision-making abilities and the ability to apply creative solutions.

Other Requirements:

Strong verbal and written communication skills.
Ability to manage multiple priorities and work in a fast-paced environment.
Knowledge of country regulatory guidelines and requirements.
Travel required: 50-75%.

Lilly Overview:
Lilly is a global healthcare leader, committed to discovering and bringing life-changing medicines to those who need them. We work to improve the understanding and management of disease and give back to our communities through philanthropy and volunteerism.

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Associate Director - Clinical Research Lead

Job Description

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