What are the responsibilities and job description for the Director of Clinical Trial Operations position at Abyrx?
Position Summary:
The Director of Clinical Trial Operations is responsible for the execution of clinical studies and data collection. The Director of Clinical Trial Operations incumbent reviews, monitors and adheres to protocols, as well as fulfills activities related to study completion. The Director of Clinical Trial Operations will interact internally and externally, and with members of a cross functional study team. The position necessitates 100% on-site presence to support team collaboration and operational needs.
Requirements
- Minimum bachelor’s degree in a health-care related field; Advanced degree strongly preferred.
- Minimum 9 years of related work experience or an equivalent combination of education and work experience
- Minimum 7 years of experience managing device-related clinical trials, CCRP Certification strongly preferred
- Experience in orthopedics and/or cardiovascular trials preferred.
Essential Job Functions and Responsibilities:
- Possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area
- Provide oversight across all functional areas for clinical studies, including the design, planning, execution, and leadership of clinical studies and clinical programs in support of Abyrx's objectives for product development and/or commercialization
- Develops documents including synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Study Report (CSR) development, etc.
· Deep understanding of statistical design, method, risk-based sample size, and analytical procedures for studies
- Deep understanding of subject recruitment/retention strategy and related initiatives
- Develop training materials for study team, investigational sites, and vendors
- Ensure clinical studies are compliant with ICH/GCP, EU MDR 2017/745, and other regulations including ISO 14155 as appropriate
- Interacts with key stakeholders to assist in clinical strategy, the development of study plans, and project deliverables
- Facilitates clinical communication within the organization, and, if applicable, CRO, and provides progress reports on clinical projects by writing assigned clinical portions of reports
- Negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed.
- Acts as liaison with Product Development, Quality Affairs, and Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed
- Perform study risk management, recommend, and with minimal guidance implement mitigations
- Identify potential study issues and recommend, and with minimal guidance implement solutions or corrective actions as needed