Clinical Trial Manager

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 liaises 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.

Requirements:

• A minimum of a Bachelor's degree or equivalent is required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• A minimum of ten years clinical operations experience
• A minimum of three years of experience leading clinical trials from start-up to database lock
• Experience with all three parts of leading a global Phase 2 and/or Phase 3 clinical trial: start up, treatment phase and database lock.
• Experience in start up and oversight of central lab, including depth specification review.
• Knowledge of sample collect and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests.
• Experience with data privacy and GDPR guidelines.
• Experience with the independent management and oversight of CROs/vendors required.
• Experience with double blind/placebo controlled studies required.
• Experience within a small biotech organization and flexibility to pivot quickly and think outside the box.
• Excellent attention to detail, accuracy in work and possesses strong analytical skills.
• Must think critically and creatively and be able to work independently to determine appropriate actions to resolve complex problems.
• Comprehensive knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials