Description
Description:The Clinical Project Manager is accountable for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and closeout activities. Manages overall operation of the entire clinical study including project planning, budget, resource management and contract research organization management. Manages clinical operational plan, and incorporates the study and scientific plan. May develop study related documents and overall direction for the clinical sites to establish protocol development. Uses statistical analysis systems, such as SAS, as appropriate. Ensures compliance with good clinical practices, good manufacturing practices and regulatory guidelines. Recommends and implements innovative process ideas to impact clinical trials management. May develop and manage clinical budget and develop contingency plans for clinical trials. Oversees clinical trials staff and manages all aspects of clinical operational plan. Responsible for managing full scope of study, protocol and scientific publications. Acts as a cross functional liaison to ensure study plan aligns with business development strategies. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
DUTIES AND JOB RESPONSIBILITIES:
- Ensure that trial timelines, costs, and quality metrics are met. Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Serve as primary contact for service provider and/or functional area representatives in managing protocol execution.
- Perform ongoing vendor management (e.g., CROs, IVRS, Bio Imaging Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
- Create and manage clinical trial budgets and staffing/resourcing plans
- Oversee forecasting of clinical/non-clinical supplies
- Ensure accuracy and timeliness of vendor and site payments.
- Provide study-specific direction to CRO, Clinical Coordinator and support staff as appropriate
- Ensure trial adherence to ICH/GCP/local regulations.
- Participate in clinical operations initiatives and programs as assigned
- 15% Travel may be required
Requirements:
- Bachelor's Degree in Life Science, or equivalent job experience.
- 3-5 years industry experience in drug development of clinical research experience
- Therapeutic knowledge in autoimmune or oncology preferred
- Knowledge of GCP and ICH
- Developed leadership skills to build and direct the execution of clinical study and to ensure that timeline, cost and quality metrics are met.
- Develops realistic trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
- Effective in a variety of formal presentation settings, one on one, small and large groups. Writing skills are proficient.
- Maintains and applies current knowledge of regulations, clinical development process, clinical trial methodology and therapeutic area to study plans. Seeks out industry intelligence; communicates information appropriately.
- Solves difficult problems with effective solutions, can see underlying or hidden problems or patterns and proactively presents of implement correction actions.
- Collaborates effectively with study teams, cross-functional team members, and external partners
- Proficient computer skills
To find out more about Real please visit www.realstaffing.com