Manager Clinical Trials (Remote) - Neurology

Scheduled Hours40

Position SummaryThis position supports and assists in the operational planning, management and execution of multiple phase II/III international trials for the Dominantly Inherited Alzheimer Network Trial Unit (DIAN-TU) conducted in accordance with ICH/GCP and local regional requirements from protocol concept through clinical study report. This position contributes to the development of trial-related scopes of work, costs, timelines, metrics, and deliverables. This position will ensure the completion of study deliverables, milestones and objectives through management of assigned study conduct including oversight of trial CROs and vendors, coordination of internal team and core members and/or external vendors, and providing support to trial teams.

Job Description

Primary Duties & Responsibilities:

Leadership of the Functional Research Groups

• Management and oversight of CROs and vendors including, but not limited to: data management (EDC), central lab, central read (MRI, ECG, etc.), IVRS/IWR, home health nursing network, clinical supplies packaging, global CRO (project management, monitoring, regulatory affairs), and pharmacovigilance.
• Collaborates with all relevant groups: multiple pharmaceutical partners; Project Arm Leaders; the DIAN-TU Trial Cores: Biomarker, Biostatistics, Clinical, Cognition, Genetics, Imaging; Trial Project Leaders; CRO(s); vendor(s); investigational sites, and subject matter experts to develop and manage clinical project timelines.
• Supports full scope of study conduct (Clinical Operations) in collaboration with Administrative Operations to ensure the trial(s) are implemented and conducted according to the Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and WU SOPs.
• Manages to and within timeline and prepares project tracking system with current trial(s) status and provides accurate progress reports on assigned trial(s) as requested.
• Contributes to implementation of quality oversight measures and processes for all areas of the trial(s). Identification of trial issues or quality issues for escalation and remediation.
• Contributes to protocol and amendment development and Clinical Operations feasibility assessments.
• Collaborates with pharma partners to ensure appropriate and timely drug supply for assigned trial(s), including oversight of expiry, quantities, etc.
• Participation in the selection of CRO and all clinical vendors/components (biomarkers, imaging, data management) for assigned trial(s).
• Partners with CRO and/or applicable team for resolution of recruitment and site performance issues.
• Planning and participation in investigator meeting(s) in collaboration with all cross-functional team members.

Other Functions

• Other duties as assigned.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job …