The Clinical Trial Manager is responsible for timely execution of clinical studies such as site feasibility, pre-qualification, site initiation, routine monitoring and study close out activities. Ensures compliance with SOP’s and Good Clinical Practice. Oversees and manages CRO’s, study contractors and vendors. Coordinates training of junior staff involved in clinical trial management.

Duties/Responsibilities:

• Assist in the preparation and finalization of project and study-related documents including informed consent forms, pharmacy/lab manual, monitoring plans, synopses, protocols and amendments, IND annual updates and clinical summaries, as required.
• Participate in the selection of clinical investigators and clinical study sites.
• Responsible for responding to clinical study site and study related issues and recommending corrective actions and/or escalating to supervisor.
• Coordinate the design, format, and content of CRFs, study guides, study reference binders, patient diaries, and study logs/forms including participating in the EDC and IVRS specification process and user acceptance testing.
• Ensure that CRF and vendor data queries are resolved appropriately and support site/CRO staff as needed.
• Coordinate and manage Investigational Product including shipment logistics, overall accountability and reconciliation.
• Coordinates the preparation and reconciliation of clinical site budgets.
• Manage project timelines and vendor performance to meet departmental and corporate goals.
• Manage payment process (i.e., study site invoices, field monitor invoices, etc.) for all clinical trial study sites and field monitors, and/or vendors.
• Monitor and track clinical trial progress and provide status update reports and study metrics.
• Manage all clinical trial vendors (e.g., IVRS, central labs, IRB, imaging, central ECG, etc.).
• Responsible for selection of CRO study staff and coordinating training including documentation.
• Manages the training and oversees study contract field monitors (e.g., review of all trip reports) and provide guidance on clinical study site issues.
• Lead with minimal supervision in the planning of investigator meetings and making presentations, as required.
• Lead with minimal supervision in the review of clinical data at the CRF, data listing, and report table levels.
• Attend and/or participate in Site Initiation Visits (SIVs) and or Investigator Meetings as required.
• Co-Monitoring with field monitor(s) for adherence to protocol and GCP as required.
• Ensure all trip reports are reviewed and all action items are followed up per SOPs and work instructions.
• Identify and escalate site, vendor and study-related issues to supervisor, as appropriate.
• Assist with Department compliance initiatives and SOP writing when opportunity arises.

Qualifications:

• This position requires a minimum of 8 years of experience in the pharmaceutical/clinical research environment with at least 4 years of study management, preferably in oncology.
• People Management is a plus.
• Ability to exercise independent judgment.
• Good organization and planning skills.
• Strong interpersonal skills and communication skills (both written and oral).
• Excellent comprehension of Good Clinical Practices and basic concepts of clinical research.
• Must be willing to travel at least 15%-20% of the time.

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.