Frontier Medicines

Clinical Research

• Support day-to-day activities within one or more clinical trials, including country/site feasibility assessments, site selection, start-up, maintenance, and close-out.
• Serve as a key operational point of contact for CROs and trial sites, identifying and escalating potential issues as needed.
• Assist with oversight of CRO and vendor set-up, liaising with CROs to ensure timely study initiation.
• Review site-level regulatory documents (e.g., Informed Consent Forms, essential documents) and escalate to appropriate stakeholders as needed.
• Help ensure inspection readiness, TMF quality, and adherence to protocol and regulatory requirements.
• Proactively identify potential operational challenges and, in partnership with senior team members, propose mitigation plans to keep study execution on track.
• Assist with review of protocols, master template informed consent forms, case report forms, and other clinical study documents as needed.
• Monitor study performance metrics, timelines, and deliverables, and review CRO trip reports for trends and quality issues.
• Track study budgets and vendor invoices/change orders in partnership with Clinical Operations and Finance, flagging discrepancies as needed.
• Help maintain timely and accurate study registration and updates on ClinicalTrials.gov and other applicable registries.
• Coordinate Clinical Trial Team meetings and drive action item follow-up.
• Maintain clinical operations trackers, databases, and document repositories.
• Provide regular study updates to internal stakeholders and support enrollment, database lock, and study closeout activities.

Clinical Trial Manager