Unblinded Clinical Trial Manager

Unblinded Clinical Trial Manager

WORK MODEL: REMOTE, CONTRACT POSITION

IS THIS A SHIFT ROLE?: NO

LIST SHIFT INFORMATION: N/A

REPORTS TO: ASSOCIATE DIRECTOR, GLOBAL CLINICAL OPERATIONS

WILL THIS ROLE HAVE DIRECT REPORTS AND IF SO, HOW MANY: NO

Position Summary

ultraimpact – Make a difference for those who need it most

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 within timelines and budget.

Responsibilities

· May participate in protocol authoring, eCRF development, Clinical Study Report preparation, and partnering with Study Management Team in assessing site feasibility for site selection.

· Oversee the development and review of study-related documents, processes, and manuals that interface with unblinded activities. (e.g., Site Specific Blinding Plans, Pharmacy Manual, Study Reference Binder, etc.).

· Provide oversight, direction, and serve as the Sponsor escalation point for an unblinded CRO team (i.e. unblinded CRAs and CTMs), including but not limited to activities such as:

o Unblinded monitoring oversight, including unblinded site trip report reviews

o Serving as the liaison to the Sponsor Clinical Supply team and IXRS vendor for patient dosing issues

o Resolving pharmacy manual and associated Investigational Product (IP) questions

o Oversight and maintenance of the unblinded eTMF

o Serve as the Sponsor point of contact for clinical trial site pharmacies and unblinded teams

· Track and document potential/actual unblinding events to completion.

· Partner with Clinical Supply Operations and Clinical Operations to ensure: appropriate setup of the IXRS system (if applicable) and randomization

specifications; adequate IP supply for each study site; prompt resolution of supply issues.

· Participate in periodic Study Management Team (SMT) risk reviews. Ongoing identification of unblinded areas of concern and/or risks, with escalation to the Blinded Study Lead and Study Management Team.

· Support the Quality Assurance team in their audits of unblinded study components.

· Provide input and review of SOPs, Work Instructions, and guidelines.

Requirements

· Bachelor degree or equivalent is required (scientific or healthcare discipline preferred).

· At least 6 years of direct work experience in Clinical Research, with experience from study start up through closeout preferred.

· Able to handle multiple tasks and deadlines, and identify risks and issues and take appropriate actions.

· Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter-organizational impact.

· Excellent planning, organizational, and communication skills.

· Must have the ability to build and maintain positive relationships with management, peers and clinical sites.

· Willing to travel domestically, up to 10%.