Manager - Clinical Research Lead

3+ years

Not Disclosed

Remote

10 Jan. 29, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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: Manager - Clinical Research Lead
Location: Praha 8, Czechia
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-76219

Company Overview:
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 are driven to discover and deliver life-changing medicines to those who need them. We are committed to improving the understanding and management of diseases, as well as giving back to our communities through philanthropy and volunteerism. If you're passionate about making a global impact and dedicated to innovation, come join our team!

Position Overview:

The Clinical Research Lead (CRL) is responsible for overseeing clinical investigators and sites involved in Lilly clinical trials and Post Marketing Safety Studies. This role includes site identification and qualification, enrollment management, and ensuring the timely delivery of clinical trial objectives. The CRL is accountable for driving superior site performance, vendor monitoring activities, and ensuring continuous inspection readiness. This role works to deliver high-quality interactions and customer experience with global trial sites, collaborating with internal and external stakeholders to resolve any issues that arise.

Key Responsibilities:

1. Clinical Investigator Management:

Oversee all activities at clinical trial sites, from site identification and qualification to database lock and trial close-out.
Manage trial enrollment, ensuring timely recruitment and data quality.
Develop strategic relationships with investigators and sites to optimize clinical trial program delivery.
Identify opportunities to accelerate trial enrollment and enhance site performance.
Ensure a comprehensive, high-quality investigator experience throughout the trial process.

2. Clinical Trial Management:

Implement risk management plans to ensure clinical trial milestones are met.
Ensure sites remain inspection-ready at all times.
Use metrics to inform decision-making and address challenges at the site and country level.
Collaborate with cross-functional teams to address barriers to trial execution.
Understand local treatment paradigms to support trial feasibility and allocation.

3. Business Management and Engagement:

Build and maintain strong relationships with clinical investigators and site personnel.
Collaborate across functions to ensure alignment with priorities and deliver trial milestones.
Prospect sites in line with portfolio strategy.
Serve as the primary communication bridge between sites, third-party vendors, and Lilly.
Influence internal and external stakeholders to improve trial execution and outcomes.

4. Country/Regulatory Engagement (as needed):

Represent Lilly Investigator Engagement in regulatory bodies and national authorities.
Engage with pharmaceutical associations and other external clinical development entities to influence industry improvements.
Ensure compliance with local regulatory requirements, incorporating these into internal processes and procedures.

Minimum Qualifications:

Bachelor’s degree (scientific or health-related field preferred).
Minimum 3 years of experience in the pharmaceutical industry or clinical research, with strong knowledge of Good Clinical Practice (GCP).
Therapeutic expertise and understanding of the clinical research landscape.
Proven leadership skills, including the ability to influence and remove barriers in a fast-paced environment.
Strong self-management and organizational skills.
Fluent in English and local language(s) required for business communication.

Preferred Qualifications:

Strong experience in clinical research trial management and vendor oversight.
Strategic agility and strong business acumen to drive trial success.
Demonstrated customer experience improvement and effective communication skills.
Knowledge of regulatory guidelines in the local country and therapeutic expertise.
Ability to travel frequently (50-75%).

Additional Information:
Lilly is committed to providing equal opportunities for all individuals, including those with disabilities. If you require accommodation to submit your resume or for any part of the application process, please complete the accommodation request form here.

Note: Lilly does not discriminate on the basis of 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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Manager - Clinical Research Lead

Job Description

Position Overview:

Key Responsibilities:

Minimum Qualifications:

Preferred Qualifications:

#WeAreLilly

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