Clinical Trial Manager
- $49,150.00 - 64,600.00 / Year *
- Hardin, KY 42048
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
Job Summary: The Clinical Trial Manager is responsible for assisting with the planning and execution of clinical trial projects and provides support for clinical trial operations including but not limited to, interacting with the Contract Research Organizations (CROs)/vendors, field clinical research associates (CRAs), clinical investigative sites, and providing general support of the clinical operational activities of the company. Works under general guidance. Job Duties: Supports clinical operations by ensuring assigned trial activities s are completed on time and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP Participates in the development and implementation of the operational plans for each [assigned] clinical project Drafts and coordinates review of relevant documents, as assigned, including: protocols, informed consent forms, case report forms, laboratory/monitoring plans, and clinical study reports. Manages Clinical Research Organizations (CROs) and vendor activities to ensure adherence to deliverables and timelines. May train CROs, vendors, investigators, and study coordinators on study requirements. May serve as point of contact for the CRO, addressing questions and applying knowledge to resolve problems Reviews the progress of assigned activities and identifies issues that require attention and recommends issue resolution Ensures that all appropriate documents and instructional materials in support of assigned activities during study start-up and study execution are completed accurately; and maintained and updated as required based on study needs Oversees and disseminates the GMI clinical reviews from the monitoring visit reports and notifies the team of significant or relevant project issues Coordinates development and distribution of site study tools, worksheets, logs, and other site documents specific to the study which can include site training materials and subject recruitment strategies Coordinates investigational product distribution and disposition ensuring the blind is maintained, as appropriate Ensures the ongoing compilation and reconciliation of the Trial Master File Complies with all applicable policies regarding health, safety, and environmental policies Job Requirements: BS in life sciences or related area and at least 4-6 years of clinical trial/clinical operations experience in a biopharmaceutical organization or equivalent. Must have previous onsite and independent monitoring experience. Previous clinical monitoring in oncology desired Thorough knowledge of FDA regulations and ICH guidelines in IND clinical trials Experience developing site monitoring strategies and risk mitigation strategies Proven track record developing tools and processes that increase efficiencies of the project Excellent communication skills, including presentation and writing skills Good interpersonal skills; ability to actively maintain good professional relationships with diplomacy and poise Must be proficient in MSOffice including, Word, Excel and PowerPoint; Adobe Acrobat, and Microsoft Project Strong organizational and time management skills; detail oriented Able to anticipate obstacles and proactively develop solutions Working knowledge of IND safety reporting Must be able to travel 10-20% [domestic and international] IndSJ2020
Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator