Propharma Group - Western Springs, IL
posted about 2 months ago
The Senior Clinical Project Manager position at ProPharma is a pivotal role responsible for overseeing and conducting clinical research trials. This position ensures that clinical trials are executed in accordance with applicable regulations and that the quality of clinical data generated meets the requirements for Regulatory Authority approval. The Senior Clinical Project Manager will provide strategic and tactical operational planning and execution of all phases of clinical programs, managing assigned studies from start to close out while overseeing project timelines and budgets. In this role, the Senior Clinical Project Manager will proactively anticipate and understand concerns, issues, and delays in the project, developing risk assessments and contingency plans as necessary. They will hold each functional area accountable for associated risk mitigation and management, serving as the primary source of communication for the clinical project team as well as cross-functional project teams, both internal and external stakeholders. Participation in project kick-off meetings, providing regular updates to clients, and ensuring effective communication between team members and clients are essential responsibilities. The position also involves monitoring project budgets against costs, ensuring timely execution of change orders to meet project margins, and tracking and forecasting budgets, metrics, and timelines for all project deliverables. The Senior Clinical Project Manager will gather metrics from cross-functional areas related to project progress and provide study-specific training for the assigned clinical operations staff. They will evaluate and identify resourcing needs, continuously monitoring the lifecycle of the study, and develop, analyze, and report study metrics to the Sponsor as per the Project Plan, proactively identifying and communicating any risks or concerns. Additionally, the Senior Clinical Project Manager will develop and maintain Study Project Plans, including site selection and monitoring plans, TMF management plans, and payment plans. They will also be responsible for creating, training, and updating study-specific tools and templates used throughout the trial. This role requires strategic input into study documents such as study synopsis, protocol, ICF, CRFs, and Clinical Study Report development, among others. The Senior Clinical Project Manager will manage study drug product and non-drug site supplies, oversee the planning and execution of Investigator Meetings, and ensure compliance with applicable FDA/ex-US regulations, ICH-GCPs, and corporate SOPs. The position also involves developing subject recruitment and retention strategies, collaborating with other functional areas to identify and evaluate fundamental issues on study-related projects, and leading or participating in investigator, client, and cross-functional team meetings. The Senior Clinical Project Manager will oversee the maintenance and quality review of the study TMF and develop tools for managing study deliverables, ensuring adherence to monitoring plans and TMF plans.