Clinical Trial Manager

Job Summary:

The Clinical Trial Manager is responsible for the timely execution of clinical studies by directing site feasibility, pre-qualification, site initiation, routine monitoring and study close out activities. The CTM 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 and identifies, mitigates, and escalates risks and issues.

Job Duties and 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.
• Ensure study documents are updated as needed throughout the trial.
• 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.
• Oversee management of TMF, ongoing quality review and final reconciliation.
• 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 data queries are resolved appropriately.
• Coordinate and manage Investigational Product including shipment logistics, overall accountability, and reconciliation.
• Coordinates the preparation 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.
• Support Internal and Health Authority inspections and audits as required, including driving inspection/audit readiness through life of the study.

Experience:

• 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.
• Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
• Knowledge of study tools including electronic system, such as CTMS, EDC, IRT, and eTMFs.
• 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% of the time.

Work Location:

The work location can be hybrid or remote. 

Compensation:

$135,000 - $155,000