Clinical Trial Manager
The Clinical Trial Manager manages and leads the day-to-day clinical trial activities related to the development and execution of cross-functional and third-party vendor activities and deliverables. Additional responsibilities include Independent oversight of outsourced clinical studies, protocol review for operational feasibility and consistency, CRO/vendor feasibility, request for proposal and bid defense process, country/site feasibility, tracking site selection, activation, and patient recruitment. The Clinical Trial Manager will also focus on the management of project timelines, relevant study plans (e.g. monitoring, study operations, quality, communications, etc.), EDC and IXRS set up and development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines).
Essential Responsibilities:
•Clinical operations leader and main point of contact with counterpart at outside vendor, CRO and/or trial sites; daily review and identification of potential issues or problems and communicates/escalates to project team.
•Assist in the critical development and review of key study documents (e.g. Protocols, ICF, study plans eCRF, etc.).
•Develop, maintain and promote effective and collaborative working relationships with and among internal team members and external vendors and 3rd party personnel.
•Participate in Clinical Operations meetings as assigned.
•Lead reviews of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings, and figures.
•Work with junior CTM for oversight of in-house review of site monitoring reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues.
•Work with junior CTM for oversight of Trial Master Files (TMF) oversight plan and laisses with CRO for annual quality check; ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents.
•Track patient and recruitment status using applicable spreadsheets and web portal tools.
•Assist in yearly IND updates including IBs and DSUR.