The ideal candidate will have 5+ years of
experience with clinical trial management (including site and CRO/vendor
management) with previous experience with medical device clinical trials. The candidate will have strong working knowledge of GCP, ICH guidelines and FDA regulations.
- Collaborate with internal and external team members for the planning and execution of clinical trials.
- Lead/oversee operational activities to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly
- Assist with development and management of project timelines and budgets; help ensure project deliverables are on time and within agreed upon budget and amended accordingly
- Ensure clinical trials meet time, quality and cost targets consistent with the overall Clinical Development Plan
- Lead the development of and provide input into study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
- Contribute to department process development, such as the development and writing of Standard Operating Procedures (SOPs)
- Collaborate with legal and finance (and others, as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, payment terms, etc.)
- Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures
- Monitor clinical study site activities and visit sites as needed
- Track, collect, and review clinical documentation for clinical trials or ensure this is being done by CRO or internal staff
Sthree US is acting as an Employment Business in relation to this vacancy.