The Unblinded Clinical Trial Manager (UCTM) is responsible for leading the unblinded portions of one or more clinical trials. The UCTM is responsible for the day-to-day management and oversight of the unblinded portions of a blinded clinical trial including, but not limited to: vendors with unblinded data, blinded clinical monitors and clinical trial site pharmacies. The UCTM is also accountable for ensuring high quality deliverables are within timelines and budget.
Responsibilities
Support the Program Lead during the Protocol Development process
Participate in protocol, eCRF development, and Clinical Study Report preparation, as appropriate
Participate in protocol and site feasibility assessments
Identify study risks, develop and implement mitigation strategies; proactively manage the study and associated risks through key risk and performance indicators.
Oversee the development and review of study-related documents and manuals that interface with unblided activities. (e.g., Pharmacy Manual Study Reference Binder, etc.)
Serve as a liaison and resource for clinical trial sites pharmacies and unblinded teams
Review unblinded site visit reports
Ensure Unblinded study team processes are in place and training is developed and delivered, working with CRO, contractors, and internal staff.
Provide a single point of contact for routine support of unblinded CRAs, unblinded site staff, and unblinded study team members; this includes system issues, patient dosing issues, and other questions.
Working close with PPD and unblinded sites staff to ensure oversight of unblinded site activities
Track and document potential/actual unblinding events to completion
Interface with Clinical Supply Operations to ensure prompt resolution of regarding any supply issues and ensure adequate supply for study sites
Consult with Unblinded and CRO staff regarding safety and dosing issues. If necessary, consult with PPD unblinded Medical Monitor in a blinded fashion regarding safety and dosing issues.
Conduct co-monitoring visits (on site or remote), to verify the quality of unblinded monitoring visit performance
Review of CRO’s unblinded eTMF maintenance or direct filing of documentation provided by uCRAs to ensure timely and accurate submission of study documents according to the plan
Identify any areas of concern and risks within assigned clinical trials and report them to Blinded Study Lead
Assists PPD in CIC package distribution and CIC meeting follow-up
Review randomization and/or IVRS specifications and ensure system accuracy and process compliance
Participate in team meetings as assigned to escalate issues and discuss lessons learned
Facilitates drug transfer, return, and destruction at site closure
Assist in Investigational Product reconciliation at database lock, interim analyses, and other unblinding activities requiring reconciliation including ongoing monitoring activities
Support the audit response team for findings related to blinded Investigational Product
Provide input and review SOPs, Working Instructions and guidelines as well as support internal audits
Qualifications
Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
Minimum 4-6 years clinical trial experience with demonstrated ability to lead study teams
Working knowledge of ICH Good Clinical Practice guidelines
Experience with international trials is preferred
Able to handle multiple tasks and deadlines
Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
Highly effective verbal and written communication skills
Must have the ability to build and maintain positive relationships with management, peers and clinical sites
Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
Willing to travel domestically and internationally
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Green Key Resources by 2x