Senior Clinical Trial Manager

at Parexel in Boise, Idaho, United States

Parexel FSP has an exciting opportunity for a Sr. CTM . This candidate is responsible for :

+ Manages all operational aspects for implementation of one or more clinical trials and all activities from study start-up through database lock, ensuring Good Clinical Practices ( GCP ) and relevant SOPs are met

+ Manages study-related service providers and serves as the primary point of contact for contracted CROs, study staff, and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate

Study Start Up

+ Participates in CRO selection process, validates clinical scope of work, supports auxiliary service outsourcing, provides input into vendor management plan, reviews quality metrics, and shares lessons learned as required

+ Manages and executes vendor kick off meetings, face-to-face meetings, team training, and trial WebEx as required for trial execution

+ Reviews and oversees the development, review, and operational aspects of site investigator grants and grant payment in accordance with sponsor process requirements

+ Provides operational review and content to the study protocol and coordinates completion of QC review of the protocol

+ Coordinates and manages investigator meetings including development of the agenda, management of slide development and review, coordination of meeting planner activities, and presenting at investigator meeting

+ Coordinates the CROs on site selection, IRB submissions, site initiation and close-out planning

Clinical Trial Operational Delivery

+ Leads and/or supports clinical operational team meetings in support of the respective clinical trial including drafting agenda, collecting minutes, filing minutes in the TMF , tracking action items, providing ongoing status of trial enrollment and timelines, outlining vendor related deliverables, communicating risk/issues, and managing input from other internal and external partners

+ Conducts thorough review of key specification documents related to the trial and oversees/participates in User Acceptance Testing ( UAT ) for Interactive Response Technology ( IRT ), Electronic Data Capture ( EDC ), eDiary and other systems

+ Provides content for study related systems and portals

+ Serves as the clinical operations representative on team meetings held by other functions and provides necessary input into key process related documents

+ Approves study invoices related to trial vendors

+ Tra