Director Clinical Operations Jobs

Albion Rye Associates are looking for a Director of Clinical Operations, the candidate will be responsible for the oversight of multiple clinical trials and projects to ensure that these trials are conducted within FDA protocols, GCP, departmental and corporate goals, Developing and leading the clinical operations team. Providing leadership & direction to the clinical operations team, and the management of CROs and other 3rd party vendors.

The Ideal Candidate will have a BS or Ph.D. in the life science field or healthcare, and over 10 years of exposure to clinical operations and trials, with a background in Project Management. Able to manage cross-functional teams while leading with a resilient and agile problem-solving approach. An individual who brings solutions to the table with the ability to manage cross-functional teams will excel in this role.

• Execute clinical studies according to ICH/GCP guidelines, and FDA regulations, from startup through closeout
• Lead the development of study protocols, study SOPs, ICF forms, CRFs, etc.
• Supervise, oversee, and maintain communication with CRO and other third-party vendors
• Oversees the creation of study budget, monitoring, recruitment, and timeline plans
• Leading vendor selection/site selection processes and vendor management
• Lead a cross-functional team including clinical operations, data management, regulatory affairs, pharmacovigilance, biostatistics, etc.
• Produce and present reports on key performance indicators and other significant benchmarking metrics, and implement plans to address variability and poor performance.
• Responsible for optimizing clinical operations, reviewing study metrics
• Planning, executing, managing, and oversight of Clinical Trials in accordance with company SOPs, regulations, and ICH/GCP guidelines

• Experience with oncology and cell therapy
• Cross-functional team leader, willing to lead meetings across multiple departments
• Willing to consider Hybrid working
• 3 years overseeing clinical trials as a study manager, CTM, CPM, or A/D of Clin Ops or above with an additional 5 years in clinical trials.
• BS/BA in a science-related field or higher
• A proven track record of successfully working in a study start-up environment, to develop and implement study plans accordingly