If you share our passion for advancing new medicines to benefit patients with virus-associated cancers and other serious diseases, please submit your resume.
Clinical Trial Manager
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.
- 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.
The work location can be hybrid or remote.
$135,000 - $155,000
If you are interested in this position, please apply: Here.