Clinical Trial Leader

Clinical Trial Leader

Position Summary  
The Clinical Trial Leader 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 RLT clinical trials from inception to final report, including leading clinical trial teams and management of clinical trial managers and contract service providers (CROs and other vendors). Reporting to the Head of Clinical Operations, the position is not only crucial for operational leadership but also for establishing and maintaining effective relationships with clinical study sites and experts in healthcare and science.  This position can be based out of our Cambridge, MA. USA or Oslo, Norway locations with a preference for east coast time zone.

Key Responsibilities:  

Site Management: Oversee day-to-day interactions with clinical sites, including training, co-monitoring visits, and issue resolution, with a focus on RLT sites equipped for radiation handling and imaging. Site engagement activities.   

eTMF Oversight: Manage the internal electronic trial master file (eTMF) if kept in-house, ensuring all documents are complete, compliant, and audit ready. Otherwise ensure eTMF managed by CRO is kept up-dated and maintained at highest quality.

IXRS Management: Lead the setup and maintenance of interactive voice/web response systems (IXRS/IVRS/IWRS) for patient randomization, drug dispensing, and dosimetry tracking.

CRO Coordination and Oversight: Serve as the primary point of contact for CROs, monitoring performance, deliverables, and alignment with trial objectives.  

Operational Execution: Provide operational leadership, 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.  

Qualifications:

• 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.  
• Previous experience as CRA desired.
• Experience in oncology required.
• Familiarity with RLT trials, including dosimetry integration and radiation safety.  
• Strong organizational skills, with ability to multitask in a dynamic environment.
• Experience in clinical supply, drug supply management or supply chain in biotech or pharma would be a big plus.
• Certification in clinical research (e.g., CCRP) a plus.  

Compensation:
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 for US hires is $130,000 – $180,000, complemented by eligibility for an annual discretionary performance-based bonus, equity participation, and a comprehensive benefits program.  For hires in Norway and the European Union, compensation will be provided in local currency and aligned with market benchmarks for comparable roles in the relevant country. Consistent with local regulations and transparency practices, specific salary ranges will be communicated during the hiring process.

Actual compensation will be determined based on factors such as role scope, location, experience and individual qualifications.

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.