Clinical Trial Manager
Posting ID: 7372461
Manages the operational aspects of assigned clinical trials, including liaising with investigational sites, conducting on-site monitoring and/or co-monitoring visits, and managing external vendors/disciplines and contract Clinical Research Associates (CRAs). Develops study specific tools and documents and provides overall direction for the clinical sites and study team members. Ensures that clinical trials are conducted according to the study protocol and in compliance with all applicable SOPs and regulatory guidelines. Recommends and implements innovative process ideas to positively impact clinical trials management. Possesses the ability to work efficiently in a fast-paced virtual environment.
- As applicable, liaise directly with sites on start-up documentation collection, review and release for drug shipment.
- Assist to provide oversight of investigational sites to ensure accuracy of clinical safety event reporting, accuracy and validity of reported data, assistance with resolution of data queries, accuracy of drug accountability, review of clinical site study files to ensure compliance and other items as required
- Assist with the identification of problems and resolve any issues to ensure the successful and timely completion of projects
- Assist with the planning, coordinating and conduct of program kick-off meetings, investigator meetings, site trainings, data monitoring committee meetings and other meetings as required
- Assist with the preparation, negotiation and management of site/vendor budget, contract and payment
- Assist with the tracking of enrollment rates, receipt and review of completed eCRFs to ensure the efficient execution of a clinical trial
- Assist with writing and/or review of all project-related documents including but not limited to: protocols and amendments, budgets and requests for proposal, change orders, informed consent, case report forms, monitoring plans, statistical analysis plans, data management plans, clinical study reports, study-specific training materials, reference binders and other documents as required
- Assists in the preparation of clinical trial documents, including study protocols, amendments, model ICFs, laboratory manuals, CRF completion guidelines, study specific instructions, etc.
- Attend and participate in vendor and internal project team meetings to provide summaries of clinical study progress
- Attend conferences and scientific meetings as required and foster and develop strong relationships with site investigators and key stakeholders within the broader patient community such as foundations and advocacy groups
- Participate in the identification and recruitment of investigator sites and assist in the development of investigator/patient recruitment strategies and materials
- Participate in the review of company SOPs and quality management plans
- Performs job duties with minimal supervision and has a sound critical thinking and problem-solving skills.
- Plan, coordinate and conduct clinical monitor training meetings including protocol training, therapeutic training and site visit training
- Provide technical and scientific guidance to partnering CROs, investigator sites and other study personnel and service providers to ensure consistency in interpretation and exchange of scientific information as needed
- Support the principal liaison with internal study team members, partnering CRO's, investigator sites and other study personnel and service providers
- Work with sites/CRO(s) on IRB/EC and associated regulatory authority submissions.
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
Recruiter: Amanda Purvis
Phone: (973) 829-4446