CLINICAL PROJECT MANAGER

Job Description:    

Accountable for the delivery of one or more studies from protocol through to study report and archiving. Accountable for leading the internal and Joint Clinical Study team; lead study specific decision-making, develop strategies for increasing study efficiencies and co-ordinate issue detection, resolution and, where necessary, escalation to the Program Delivery Leads. The level of CPM assigned to a project (either CPM or Senior CPM) will be dependent on study complexity and type. Senior CPMs will be accountable for more complex studies and/or those with high visibility such as pivotal trials or challenging  

Major Accountabilities/Responsibilities 

Lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across internal and CRO/Phase 1 Unit teams. Creates or contributes to detailed planning of the study, timelines, define critical path to enable seamless access to data, early read out of bioanalytical and safety data to enable data review meetings and early decision making. • Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the CRO/Phase 1 Unit. Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate. • Supervise study conduct by regularly reviewing CRO/Phase 1 Unit performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/or impact budget. • Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.

EDUCATION - Bachelor's Degree Required

At least three years' relevant experience in clinical development including team leadership. Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multicenter clinical studies) from study start-up to study report completion. A Sr CPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end