Study Manager - Permanent - Manchester
With expertise in clinical pharmacology, regulatory affairs, pharmacokinetics, pharmacometrics, biopharmaceutics, and bioanalytical, our client specializes in the strategy, management and execution of product development and early phase clinical development. They have conducted over 1000 clinical studies, from Phase I Healthy Volunteer studies to Phase IIA Patient studies.
Now, this client of ours has a fantastic opening for a Study Manager...
Role Summary
The Study Manager must be able to objectively assess and apply project management knowledge to ensure that the project is completed in accordance with the scope, quality, timelines and cost of the contract.
Role Responsibility
Perform duties under general supervision of the Department Manager, the Director, Clinical Operation, Medical Director and PI and be responsible for all aspects of the clinical study for the life of the project.
Work with cross-functional sections/teams to deliver clinical study projects under the constraints of study scheduling and resources.
Ensure adequate staffing and training of staff working on assigned projects.
Act as the primary liaison between the project team and the client.
Ensure that all outside vendor contracts are set up and deliverables are being meet in accordance to the agreed upon work order.
Obtain and review clinical statement of work (SOW) and/or study work order (SWO) to determine what services are required for each clinical trial protocol.
Initiate and participate in the early planning phases of clinical study by providing guidance on deliverables and outsource options (i.e. assist in preparation of study proposal timelines, scheduling and other study requirements as appropriate); including but not limited to study source documents, procedural timelines and lab set up.
Work closely with clinical research coordinator to ensure adequate internal resources and resolution of any clinical study work flow issues for assigned clinical studies.
Prepare and maintain project management plan for assigned clinical studies.
Act as liaison and point of contact for all clinical study sponsors and vendors for related services.
Attend sponsor meetings and required conference calls to ensure effective communication flow between external customers and staff.
Present at Clinical Tracking Meetings.
Lead and/or participate in all study related meetings to include (clinical tracking, screen team and mock runs).
Initiate Team Meetings as required.
Track and monitor all clinical study change requests; providing information to all appropriate internal study team members.
Work with clinical studies unit and external vendors to discuss deliverables and timelines and communicate timelines to sponsor.
Clinical research experience leading and directing clinical trials
Project management experience preferred.
Excellent written and oral communication skills and interpersonal skills.
Strong problem-solving skills.
Detail-oriented with excellent organizational and prioritization skills.
Ability to work on multiple projects simultaneously and meet varied deadlines.
Ability to understand protocol requirements to apply project management knowledge to: initiate, plan, execute, monitor/control and close clinical study.
Self starter with the ability to work independently.
