Assistant Clinical Project Manager
Location: US-based / Preference within Boston
Reports To: Clinical Lead
About Draig Therapeutics
Draig Therapeutics is an exciting, rapidly growing clinical-stage biotech backed by a transformative $140 million Series A financing — one of the largest ever in neuropsychiatric drug development.
We are pioneering innovative small molecule therapies aimed at fundamentally transforming the treatment landscape for depression and neurological disorders.
With a cutting-edge pipeline advancing swiftly through clinical development, Draig offers a unique opportunity to join a visionary team committed to delivering breakthrough medicines that can significantly improve patient outcomes on a global scale.
If you want to be part of a bold, mission-driven company poised for major impact, this is the place.
Role Overview and Key Responsibilities
We are seeking an Assistant Clinical Project Manager support to the Clinical Leads on Phase 1-3 clinical studies.
You will work closely with the Clinical Leads to:
- Support with the development of the Draig Sponsor Oversight Plan.
- Review and/or QC of study plans and manuals produced by the CRO, as required.
- Attend and participate in Draig and CRO team meetings.
- Review and/or QC of Regulatory/Ethics submission packs for the participating countries to ensure accuracy and consistency of submission documentation.
- Monitor green light process for study start at the study sites, if required.
- Collaborate with data management teams at CRO including User Acceptance Testing, as required.
- Track and review pharmacovigilance activities including review of plans, safety data and other required documentation.
- Manage risk assessment activities for assigned trials
- Oversight of laboratory-related activities, to include review of laboratory documentation (manuals, plans) and tracking of sample shipment/management as required.
- Coordinate with clinical trial vendors as agreed with the Clinical Lead.
- Review monitoring activities including Trial Monitoring plans and monitoring visit reports.
- Maintain the CRO’s electronic Trial Master file including content review and completeness checks, regular formal QC checks and following up on missing documentation.
- Track clinical trial timelines, deliverables, and milestones.
Required Experience & Skills
- Strategic thinker with excellent execution and communication abilities.
- A bachelor’s degree, with a preference for this to be in Nursing or Pharmacy discipline.
- A working knowledge of GCP.
- Although a low-level need and frequency to do so, ability to travel internationally is a requirement for this role.
What We Offer
- A competitive compensation package, including equity participation in a high-growth biotech.
- Opportunity to thrive at a well-funded company with a pioneering pipeline poised to transform neuropsychiatric medicine worldwide.
- Dynamic, mission-driven culture that values innovation, collaboration, and impact.