Director of Clinical Operations
The Director of Clinical Operations reports to the Chief of Clinical Projects and Chief Operations Officer.
The Director of Clinical Operations is responsible for the overall execution of clinical trials, accountable for the study start-up activities, budget and timeline management, organization, administration, and execution of the clinical trial from start to finish. The Director of Clinical Operations must also be familiar and in compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and Standard Operating Procedure (SOP) guidelines. The Director collaborates cross-functionally within the organization and provides supporting members with key information and training.
RESPONSIBILITIES AND DUTIES INCLUDE BUT ARE NOT LIMITED TO:
· Manage staff in accordance with organizational policies, SOPs, and applicable regulations. Provide oversight and guidance on all projects assigned to clinical team members; planning, assigning, and directing work; appraising performance and guiding professional development; addressing employee relations issues and resolving problems.
· Monitor departmental staffing needs on an ongoing basis. Direct the interview, hiring, and selection process for clinical staff. Establish methods to develop and evaluate onboarding processes. Develop standard processes to ensure staff have the proper materials, systems access, and training to complete job responsibilities.
· Collaborate with senior management and cross-functional leadership to improve efficiencies, project outcomes, and quality metrics for projects.
· Actively participate in budget preparations; analyze and review budgets for projects.
· Lead the development of study related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
· May conduct assessment visits with staff as required by SOPs; Perform co-monitoring visits with Clinical Team Leads or Clinical Research Associates.
· Participate in internal project management review calls, and liaise with cross-functional leadership to ensure project delivery.
· Participate and lead client meetings and teleconferences
· Undertake other tasks as appropriate, as assigned by the Program Director
· Bachelor's degree in a health care or other scientific discipline or educational equivalent; Minimum 5 years of clinical trials experience in a leadership capacity; or equivalent combination of education, training, and experience
· Advanced knowledge and ability to apply GCP, ICH, and regulatory guidelines
· Strong leadership and management skills
· Strong computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
· Strong written, verbal, and interpersonal communication skills
· Excellent organizational and problem-solving skills
· Effective time management skills and ability to manage competing priorities
· Ability to establish and maintain effective working relationships with coworkers, managers, and clients
We believe new advancements and new technologies will be born out of ingenuity, expertise, and focused resolve. Reshaping how we think about cancer in order to reshape what we think about cancer – transforming impossibility into hope.
Cancer Insight is continuing over a decade of cancer immunotherapy research and testing developed under the military program Cancer Vaccine Development Program. Our seasoned research team, led by Dr. George Peoples, will continue to operate with the same focus, integrity and innovation to push new technologies and advance vaccine research. We have brought together decades of academic experience with business professionals in the private sector to both develop and test safe and efficient therapies and preventative strategies.