Senior Clinical Trial Lead - Associate Director

Draig Therapeutics; Boston (MA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive salary

Dynamic work environment

Opportunity for growth and development

Job summary

A progressive biotech company in Boston is seeking a Senior Clinical Trial Manager to lead clinical programs and oversee outsourced trials. The ideal candidate will have extensive experience in clinical operations and a strong understanding of ICH GCP regulations. Key duties include guiding cross-functional teams, developing clinical documents, and ensuring compliance with regulatory standards. This role requires exceptional project management skills and the ability to interpret clinical data. Join a mission-driven organization that values innovation and collaboration.

Qualifications

• Bachelor’s degree in Biological Sciences, Psychology, or Life Sciences.
• Extensive experience in oversight of outsourced clinical trials.
• Proven track record managing multiple clinical programs.
• Strong knowledge of ICH GCP and regulatory requirements.
• Experience leading cross-functional teams and managing external partners.
• Ability to interpret clinical data and provide insights.
• Advanced project management skills including budget tracking.
• Excellent knowledge of clinical trial processes and tools.
• Proven leadership and stakeholder management capabilities.
• Exceptional communication skills for status updates and presentations.
• High level of organization and attention to detail.

Responsibilities

• Provide clinical leadership across development programs.
• Oversight of outsourced trials and vendor performance.
• Develop clinical documents including trial protocols.
• Review trial data for quality and integrity.
• Interpret data to inform regulatory submissions.
• Manage clinical budgets and timelines.
• Prepare reports on trial status for senior leadership.
• Guide clinical teams and align with portfolio strategy.
• Represent clinical function at project teams and meetings.

Skills

Clinical trial management

Cross-functional collaboration

Project management

Regulatory knowledge (ICH GCP)

Data interpretation

Budget management

Education

Bachelor’s degree in a relevant scientific discipline

Tools

CTMS

EDC

eTMF

Job description

A progressive biotech company in Boston is seeking a Senior Clinical Trial Manager to lead clinical programs and oversee outsourced trials. The ideal candidate will have extensive experience in clinical operations and a strong understanding of ICH GCP regulations. Key duties include guiding cross-functional teams, developing clinical documents, and ensuring compliance with regulatory standards. This role requires exceptional project management skills and the ability to interpret clinical data. Join a mission-driven organization that values innovation and collaboration.