Summary of Position:The Unblinded Clinical Trial Manager is responsible for all unblinded operational aspects of a clinical study from setup through final report, with support from Clinical Operations Leadership. Depending on study scope and complexity, this role may coordinate activities of internal team members (e.g. Clinical Research Associates, Data Managers), and oversee multiple external vendors and consultants as needed. The Unblinded Clinical Trial Manager may also serve as the in-house Unblinded Lead Clinical Research Associate, as needed.
Position Responsibilities- Facilitate internal project team meetings as needed
- Serve as the primary unblinded point of contact for sites, vendors and CROs, pharmacists and any unblinded study staff
- Review temperature excursions; collaborate cross functionally to ensure timely resolution of site inventory non-conformances
- Assist with investigational product (IP) site forecasting as needed
- Conduct unblinded review of multiple study documents and deliverables across functions
- Review CRO Unblinded Monitoring Visit Reports (uMVRs)
- Conduct unblinded co-monitoring visits in accordance with the Sponsor Oversight Plan as needed
- Track key performance indicators (KPIs) to assess CRO CRA and site performance, ensuring compliance with ICH-GCP, SOPs, Local Regulations, Protocol and Monitoring Plans
- Manage interactions with investigators and site personnel to ensure compliance with regulatory expectations
- Proactively identify, mitigate and escalate risks or issues impacting study timelines
- Ensure the unblinded portion of the Trial Master File (TMF), maintained at the CRO, remains inspection-ready; rountinely review for compliance and oversee remediation of findings as needed
- Oversee the Site Pharmacy setup activities as needed and serve as a liaison between Sponsor and site pharmacy teams as needed
- Participate in vendor, site and CRO audits as appropriate
- Plan and present at Investigator Meetings as needed
- Adhere to departmental SOPs, GCP/ICH guidelines and applicable QC/QA procedures
- May require travel, including international travel
- Collaborate with Clinical Supply to assist in managing Interactive Response Technology (IRT)
- Participate in User Acceptance Testing (UAT) as applicable
- Participate in product recall activities, if needed
- Assist with collaboration between study sites and Sponsor to resolve product complaints
Candidate Requirements- BS/BA degree in a scientific discipline; advanced degree preferred
- Minimum of 3 years demonstrated experience in a biotech/pharmaceutical/ CRO company, clinical research site or related healthcare company
- Prior experience with a multi-phase clinical program or experience across multiple phases of clinical drug development
- Highly organized, outcome oriented, self-motivated performance
- Ability to adapt to change in a growth environment
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
- Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
- Understanding of the drug development process
- Knowledge of federal regulatory requirements and guidelines for Good Clinical Practice
- Strong written and oral communication skills
