Sr. / Dir Clinical Operations
Summary of Position:
Lead clinical operations and ensure successful completion of all clinical trials and related clinical trial milestones within established timelines and budgets and in accordance with global regulatory standards.
- Provide input for clinical development plans including creation of various clinical trial scenarios along with associated timelines, risks and costs.
- Work closely with Program Management and the Chief Medical Officer to align operational strategies with corporate goals.
- Oversee preparation of clinical documents such as protocols, consent forms, monitoring plans, study reports etc. and contribute to their writing and review.
- Review and approve clinical study conduct documents and electronic systems
- Oversee the development, implementation and utilization of relevant clinical systems to ensure Trial Master Files are audit ready and other relevant information is easily accessible.
- Supervise the selection and management of CROs and other clinical vendors and oversee clinical trial processes to ensure exemplary study conduct and data quality.
- Develop strategy and action plans for risk mitigation and resolution of any problems that arise.
- Develop and update clinical budgets and timelines and analyze variances in coordination with Program Management and Finance.
- Develop and review department policies, SOPs and quality metrics, ensuring operational excellence through ongoing evaluation and improvement of clinical processes and systems.
- Maintain a collaborative and innovative culture through the development of productive working relationships across organizational functions and regions.
Job Requirements (Essential knowledge, skills and attributes):
- Bachelor’s degree required, preferably in life science area. Advanced degree/ clinical research certification desirable.
- Detailed knowledge of the drug development process along with clinical operations management experience. Vaccine experience strongly preferred.
- At least 7 years of experience in clinical operations related roles of increasing complexity.
- Successful management of a variety of studies, Phase 1-global Phase 3, in a CRO or bio-pharma setting.
- Prior successful management of CROs and/or other vendors.
- Experience and expertise in preparation of clinical protocols, regulatory documents, SOPs, and training materials.