Assistant Clinical Project Manager - US
US
Vacancy listed 03/07/2025
Application deadline 31/07/2025
Details
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.



Notes

This vacancy may close sooner than the date provided.

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This vacancy has now been closed