Clinical Trial Leader

Clinical Trial Leader Position Summary

The Clinical Trial Leader Director serves as the day-to-day operational owner for specific RLT clinical trials, ensuring seamless execution at the site level. This hands‑on role focuses on managing trial logistics, documentation, and vendor interactions to maintain quality and compliance. Reporting to the Head of Clinical Operations, the position is crucial for overcoming RLT‑specific hurdles like interactive response systems for dosimetry and electronic trial master file integrity.

• Site Management: Oversee day‑to‑day interactions with clinical sites, including training, monitoring visits, and issue resolution, with a focus on RLT sites equipped for radiation handling and imaging.
• eTMF Oversight: Manage the electronic trial master file (eTMF), ensuring all documents are complete, compliant, and audit‑ready.
• IXRS Management: Lead the setup and maintenance of interactive voice/web response systems (IXRS/IVRS/IWRS) for patient randomization, drug dispensing, and dosimetry tracking in RLT trials.
• CRO Coordination: Serve as the primary point of contact for CROs, monitoring performance, deliverables, and alignment with trial objectives.
• Operational Execution: Handle trial logistics, including patient recruitment strategies, data query resolution, and protocol deviation management.
• Risk and Quality Management: Identify operational risks and implement corrective actions, ensuring GCP compliance and radiation safety protocols.
• Reporting and Metrics: Track key performance indicators (e.g., enrollment rates, site activation timelines) and report to leadership.
• Cross‑Functional
  
  Collaboration:
  
  Work with clinical science, regulatory, and medical teams to support trial delivery.

• Bachelor's degree in life sciences; advanced degree preferred.
• 7+ years in clinical trial management, with experience as a trial leader in biotech/pharma.
• Expertise in site operations, eTMF systems (e.g., Veeva Vault), IXRS, and CRO management.
• Familiarity with RLT trials, including dosimetry integration and radiation safety.
• Strong organizational skills, with ability to multitask in a dynamic environment.
• Certification in clinical research (e.g., CCRP) a plus.

Actithera offers a competitive compensation package designed to reward both performance and expertise through market‑based, results‑driven pay. For this role, the anticipated base salary range is $130,000 – $180,000, complemented by eligibility for an annual bonus, equity participation, and a comprehensive benefits program.

Your actual salary will be determined based on the scope of the role and your unique experience and capabilities—because we know great contributions come from great people.

Actithera is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.