Clinical Trial Manager

Role Summary

Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development.

Responsibilities

• Clinical project team member: works closely with the Sr. CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables
• Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations. Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing
• Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders
• Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation, accruals, and re-forecasting, with Clinical Outsourcing, Finance and Project Management
• Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects
• Works with Patient Recruitment department and is responsible for overall recruitment strategy, enrollment projections, and meeting established targets
• Coordinates and/or participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents
• Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact for study-level status updates
• Presents at clinical team meetings and other forums on study progress
• Works with Study Start-up and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set-up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments
• Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors
• Participates in SOP development, process mapping, training of junior CTMs and CTAs, and other departmental activities
• Direct line management and supervision of CTAs. Responsible for performance reviews and supporting professional development for direct reports

Qualifications

• Required: Science background: BS or healthcare degree required, Masters preferred
• Required: Experience: 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting

Preferred Requirements

• Monitoring experience, a plus
• Strong knowledge and understanding of GCP/ICH guidelines for conducting clinical trials
• Strong leadership, interpersonal, organizational, and multi-tasking skills
• Excellent attention to detail and problem solving skills
• Ability to work effectively in a team setting
• Travel domestic and international – up to 25%