Clinical Project Lead

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Clinical Project Lead needed for a contract opportunity with Yoh's client located in Swiftwater, PA.

- Ensure that key medical governance activities for NA are being tracked and reported and medical operational activities pertaining to execution of clinical trials are kept on time and budget. - Assists the Operations director to manage activities pertaining to medical governance and to support clinical studies conducted in NA. - Coordinate activities between the various platforms within NA ComOps and other enabling functions such as RA, PV, CMQO, GMA to ensure that medical oversight for key activities are tracked and reported. - Reviews and develops clinical trial budget for studies conducted by NA medical affairs. - Provides suggestion for adjustments and facilitates agreement with team as required to ensure that clinical teams to function efficiently to achieve milestones and goals. - Responsible for managing/coordinating the achievement of project goals for medical affairs studies. - Ensures top down/bottom up communication and provides guidance on best practices and lessons learned for operational execution of clinical trials. - Facilitates operational issue resolution and is viewed as trusted liaison with key stakeholders - Ensure the deliverables of the clinical studies conducted by medical affairs in NA (US and Canada) are on time and within budget via effective project management and develop the best operational strategy for the successful conduct of the project.

- MS or higher degree in a related discipline - 3-5 years experience in vaccinology/clinical research - Formal training in GCP methods - Proven track record in delivering high quality GCP-compliant Clinical Trials - Clinical Trial experience preferred - Knowledge of Code of Federal Regulations (US) and regulatory agency documents - Resourcefulness; ability to find solutions to operational problem - Project management, budget management experience preferred **The Big Picture - Top Skills You Should Possess:** - Experience in a pharma business in medical, regulatory and/or pharmacovigilance. - Experience with planning, feasibility evaluation, budgeting, execution, and closeout of said delegated research and/or analytical projects.