Remote - Unblinded - Clinical Trial Manager

A highly reputable global biopharmaceutical corporation is currently hiring a qualified Unblinded Clinical Trial Manager to work remotely in the United States.

Essential Job Functions:

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 CRO 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 CRO unblinded Medical Monitor in a blinded fashion regarding safety and dosing issues.
• Supervise unblinded monitoring activities (visits frequencies, trip report reviews and follow ups).
• 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 CRO 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 plus years clinical trial experience with demonstrated ability to lead study teams
• Working knowledge of ICH Good Clinical Practice guidelines
• Experienced 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