Unblinded Clinical Trial Manager - Bedford, United States - Tandym Group

Description

Our client, a leader in the pharmaceutical industry, is seeking an Unblinded Clinical Trial Manager to join their team. 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.

**This job is remote - USA**
**W2 Only**

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.
• 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 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