Associate Director - Clinical Research Lead

10+ years

Not Disclosed

Gurgaon

10 Jan. 1, 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

Join Us at Lilly: Clinical Development Consultant

At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees work to discover and deliver life-changing medicines, improve disease understanding and management, and contribute to communities through philanthropy and volunteerism. We strive to make a difference by putting people first, and we’re looking for dedicated individuals committed to improving lives across the globe.

Job Title: Clinical Development Consultant (CRL)
Location: [Location]
Reports to: [Manager/Supervisor]

Purpose:
The Clinical Development Consultant (CRL) is responsible for the comprehensive management of clinical trial sites in Lilly’s clinical research programs. This includes site identification, qualification, and enrollment, ensuring the timely delivery of clinical trial milestones like database locks, and maintaining inspection readiness. The CRL is accountable for managing site performance, resolving issues, and supporting the execution of trials within their assigned therapeutic area. The role also includes oversight of vendor monitoring activities and proactive issue mitigation at clinical sites.

Key Responsibilities:

Clinical Investigator Management
- Oversee activities at clinical trial sites, from site identification to closeout.
- Ensure timely delivery of trial milestones, including enrollment readiness and database locks.
- Build strong relationships with clinical investigators to enhance trial delivery and enrollment.
- Apply therapeutic expertise to ensure the timely recruitment and quality data collection.
Clinical Trial Management
- Develop and implement risk plans to ensure timely clinical trial delivery.
- Ensure site and country-level inspection readiness at all times.
- Leverage metrics for informed decision-making at site, country, and regional levels.
- Collaborate with internal teams to remove barriers to site execution.
- Understand local treatment paradigms to optimize trial feasibility and strategic allocation.
Business Management and Engagement
- Establish and maintain strong professional relationships with clinical investigators and vendors.
- Collaborate cross-functionally to align priorities and deliver on the clinical trial portfolio.
- Influence both internal and external stakeholders to improve clinical research delivery.
- Perform targeted site prospecting aligned with portfolio strategy.

Minimum Qualifications:

Bachelor's degree or equivalent.
8-10 years of experience in the pharmaceutical industry and clinical research, with a solid understanding of Good Clinical Practice (GCP).
Strong therapeutic knowledge and expertise in clinical research.
Demonstrated ability to manage workload, set priorities, and adapt in a dynamic environment.
Proven leadership ability, with strong decision-making skills and strategic agility.

Additional Preferences:

Bachelor’s degree in a scientific or health-related field.
Strong communication and organizational skills.
Ability to improve customer experiences and enhance stakeholder relationships.
Fluent in English and required languages for day-to-day business.
Knowledge of country-specific regulatory requirements.
Ability to develop creative solutions and demonstrate teamwork.

Travel: 50-75%

Lilly is dedicated to helping individuals with disabilities and ensures equal opportunities for all. If you require accommodation to submit a resume for this position, please complete the accommodation request form.

Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

#WeAreLilly

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Associate Director - Clinical Research Lead

Job Description

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