Sr. Manager of Clinical Affairs
- Initiate, develop and maintain liaison among physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/Registries from initiation through completion.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and reports/data presentations/publications. Manage initiation of clinical sites and study protocol training, and oversee clinical data collection, trial monitoring and auditing according to GCP guidelines and Global Policies and Standard Operating Procedures. Prepare required documentation for FDA, Canada, Japan, Europe, and other regulatory submissions, including PMA's, IDE's, 510(k) CE marked and Canadian regulatory submissions.
- Developing and conducting clinical studies/registries from initiation to completion, while ensuring study compliance and data completeness;
- Maintaining appropriate regulatory documents both internally and externally;
- Supporting sponsor site interaction for IRBs, contract, and training;
- Managing CRAs/Safety Monitors/Consultants/CROs/administrative personnel;
- Managing study documentation within the CTMS and eTMF frameworks;
- Developing and managing budgets
Sthree US is acting as an Employment Business in relation to this vacancy.