NAVICAN is seeking a Clinical Operations Manager with a background in clinical research, oncology and genomics as a key team member for our scientific and clinical team. This individual will help contribute to the execution and analysis of prospective clinical research studies supporting Navican’s current and future product offerings. This is a great opportunity for a motivated team player looking for a challenging role where they can apply the experience of best practices learned, have influence in the development of systems, and apply their talent real-time for results.
The successful candidate must be a high energy, analytical, hard-working team player with an entrepreneurial spirit, who knows and can apply best practice frameworks, processes and methods while being hands-on and highly ethical.
Primary Responsibilities and Essential Duties
- Works with the VP of Clinical and Scientific Affairs to build a clinical operations development plan. Initiates and leads daily management of prospective clinical studies, including: responsibility for vendor oversight, development of study operational plans, completion of study start up activities and ongoing maintenance of studies through completion. Works closely with Clinical Project Manager to track study progress. Interfaces with CRAs for site specific initiation, training and monitoring.
- Prepares clinical study documents, including, but not limited to: case report forms, informed consent documents, study protocols and amendments. Acts as primary point of contact for clinical operations, including ethics committee to lead submission, review and follow through for approval of protocols and consents.
- Coordinates with extended scientific team to aggregate study data for analysis.
- Innovates with internal staff and external collaborators to expand the scope of Navican’s clinical translational research studies.
- Works with Clinical and Scientific team on publication plans supporting clinical research studies.
- Contribute to new product ideas and product development.