Manager responsible for the operational management and the oversight of clinical trials within a clinical development program.
Clinical Trial Manager - Perm hire - San Diego, CA*position can be remote until COVID restrictions are lifted, but must be local to San Diego for smooth and quick transition when on-site is allowed. Position Overview This position will be responsible for the operational management and the oversight of clinical trials within a clinical development program. This individual will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. Providing oversight of the CRO and other third party vendors on assigned study. The Clinical Trial Manager will work closely with a Project Leader, or Pharmacovigilance, Regulatory, etc., and will report into the Clinical Operations Manager. Responsibilities: · Assisting in identification and hiring of appropriate CROs and third party study vendors · Assisting with CRA and third party vendor training on protocols and practices · Developing and maintaining good working relationships with investigators and study staff · Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures · Identifying, selecting, and monitoring performance of investigational sites for clinical studies · Investigating queries, monitoring discrepancies · Managing investigational product (IP) accountability and reconciliation process · Negotiating and managing the budget and the payments · Overseeing performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to Clinical Operations Manager · Performing clinical data review of data listings and summary tables, including query generation · Performing initial review of CRO and other third party study vendor invoices · Planning and conducting investigator meetings · Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team · Reviewing or approving of IP release packages · TMF maintenance · Tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits · Writing or contributing to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents Job Requirements: · At least 2 years of trial management experience · At least 6 years of clinical trial experience in Pharmaceutical, Biotech, or a CRO company is required · Bachelor’s degree or equivalent combination of education/experience in science or health-related field required · Working knowledge of GCP/ICH guidelines and the clinical development processApply For Job