- Company Name
- Kymera Therapeutics
- Job Title
- Senior Clinical Trial Manager
- Job Description
-
Job Title: Senior Clinical Trial Manager
Role Summary:
Strategically plans, executes, and oversees large, global Phase 2B/3 or late‑stage clinical trials, ensuring adherence to regulatory standards, timelines, and data integrity while coordinating cross‑functional teams and external vendors.
Expactations:
- Lead multiple complex trials simultaneously, achieving study milestones and budgetary goals.
- Serve as primary liaison among CROs, investigators, clinical staff, data management, and translational science teams.
- Maintain high standards of GCP compliance, risk management, and quality assurance.
Key Responsibilities:
- Develop and manage global trial master plans and timelines.
- Coordinate study‑specific meetings (core team, investigator, CRO, CRAs).
- Define and approve ICFs, eCRFs, monitoring protocols, and edit checks.
- Oversee site selection, qualification, initiation, and monitoring; resolve site‑related issues.
- Ensure on‑time enrollment, data capture, and database lock in collaboration with data managers.
- Review monitoring reports, protocol deviations, and adverse event summaries for safety and efficacy.
- Train and lead clinical research staff, CRO personnel, and site teams.
- Foster relationships with investigators and site staff to support trial execution.
- Identify, analyze, and resolve project risks and issues proactively.
- Maintain comprehensive, compliant trial documentation and records.
Required Skills:
- 5+ years as Senior Clinical Trial Manager in biotech/pharma.
- Proven experience with global, phase 2B/3 or late‑stage trials; respiratory or immunology background preferred.
- In‑depth knowledge of ICH GCP, FDA/EMA regulatory requirements, HIPAA, and Human Research Subject protection.
- Strong project management, multi‑project coordination, and deadline discipline.
- Excellent problem‑solving, leadership, and negotiation skills.
- Effective communication with cross‑functional teams and external stakeholders.
- Adaptability to fast‑paced, dynamic environments.
Required Education & Certifications:
- Bachelor’s degree in Life Sciences, Nursing, or related field.
- Certified Clinical Research Professional (CCRP) or equivalent preferred.