Senior Clinical Trial Manager (Contract)

Education

• B.A./B.S. degree

• Manage protocol execution, including oversight of the CRO, other study service providers, and consultants involved in a clinical trial

• Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership

• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs

• Assist in the preparation and review of clinical trial documentation, such as protocols, informed consent forms, pharmacy and laboratory manuals, clinical monitoring plans, project plans, case report forms, vendor management plans, clinical study reports, and other study-level documents

• Develop internal tracking and reporting tools to report study status to leadership and facilitate internal project team meetings

• Support the management of the Trial Master File (TMF) to ensure compliance/inspection readiness

• Participate in and coordinate the resolution of audit findings and ensure that clinical trial documentation, including central clinical files, remains audit-ready

• Identify, mitigate, and manage risks, including timely issue review, escalation, and management to support trend analysis and risk prevention

• Support the selection and study-specific training of CRO study staff, monitors, investigational sites, and service providers under the AD/Director of Clinical Operations

• Facilitate study start-up with CROs and clinical sites as necessary, including working closely with the CRO to complete template clinical documents, such as source document worksheets, CRF specifications and development, clinical site agreements, and other study documentation

• Assist data management personnel with activities associated with database lock and clinical study data analyses, and provide study-specific input to the preparation of clinical study reports as directed

• Ensure timely response to queries and monitoring discrepancies

• Aid in the planning and execution of investigator meetings

• Present during cross-functional study execution team (SET) meetings in support of study deliverables

• May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff and/or compliance personnel, including pre-study qualification visits, site initiation visits, eligibility review visits, routine study visits, trial master file review visits, and vendor qualification or selection visits

• Oversee outsourced monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issues

• Ensure tracking and review of protocol deviations and assess their impact on study data

• Provide oversight of clinical supply forecasting, including study drug and other supplies

• May manage and/or oversee the work of junior Clinical Operations staff

• May support development and review of Clinical SOPs and other department initiatives

• Travel as needed to sites, conferences, and industry meetings