Clinical Trial Manager
The Clinical Trial Manager (CTM) will report to the Director, Clinical Operations and is responsible for clinical trial execution and monitoring activities according to PaxVax Standard Operating Procedures, ICH and Guidelines
- Responsible for vendor/CRO management; including RFP review process, performance accountability; invoice review and timeline management Responsible for all aspects of study monitoring including study start-up activities; Pre-study visits Site initiation visits; routine monitoring and Close-out visits ofclinical sites; Oversee the maintenance of study files (eTMF); and other duties, as assigned Responsible for all aspects of site management as prescribed in the project plans
- Ensure that Good Clinical Practice (GCP) is incorporated in all aspects of the clinical trial(s)
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitor data for missing or implausible data; implement risk-based monitoring, as applicable
- Conduct in-house review of Case Report Forms when applicable
- Oversee the collection, review, and archive Site Essential Documents.
- Oversee ongoing document review and collection throughout study start-up, maintenance and close-out periods. Collaborate with Regulatory, Quality and other departments as necessary to ensure appropriate oversight of TMF.
- Oversee the coordination of site selection and study feasibility tasks
- Preparation and checking for completion (and cross-checking to TMF) of site activation checklists and packages.
- Participate in the preparation and ongoing review of study documents (i.e.: protocols, consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy Manual, User's Guides, Data Management Handbooks, and SOPs, etc).
- Assist in coordination of SOP reviews, departmental training and recordkeeping
- Ensure tracking of patient status throughout the study at investigative sites through collaboration with data management
- Assure appropriate oversight for collection and tracking clinical samples from clinical sites to central labs and vendors
- Provide clinical team oversight to lead – and field CRAs
- Assure timely shipment of clinical supplies (lab kits, binders, etc.) and study drug to sites in collaboration with vendors and regional CRAs
- Conduct and coordinate meetings between PaxVax and Vendors, Contract CRAs, Investigative Sites, as needed
- Maintain adequate study and site tracking records; input and maintain study information into necessary tracking systems, as needed
Technical Skills and Knowledge:
- Capable of managing all operational aspects of clinical studies
- Has the ability to deal with competing timelines and multiple assignments, prioritizing successfully
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
- Strong communication (written and oral), negotiation, organizational, and interpersonal skills.
- Must be able to collaborate and work effectively with multiple departments throughout the organization.
- Must be able to work independently and as part of a team.
- Exceptional technical and computing skills
- BA/BS degree or higher, preferably in life sciences
- 3-5 years relevant experience
- Experience overseeing Clinical Research Associates
- Appropriate medical terminology knowledge
- Vaccine clinical trial experience highly desirable
- Ability to travel up to 25% (US and International)