Surgical Manager

We have some great roles for Clinical Project Managers in Central London. We can consider part-time for this short term role.

Our client has an extensive global network of sites they work with to provide clinical trials to a range of sponsors and across various therapeutic areas, although there is a focus on cardiovascular, haematology, and oncology therapeutic areas.

If you have some clinical project management experience, working with clients to ensure studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, SOPs, and all applicable regulatory guidelines, then let us know. This could be perfect for you.

Key Responsibilities:

• Lead local/regional study management teams in the implementation of clinical trials ensuring compliance with ICH-GCP guidelines, SOPs, and all applicable regulatory requirements for the allocated study.
• Define and monitor project scope, timelines, and deliverables from project initiation to close-out. Ensure project plan aligns with contract requirements and address any reconciliation required.
• Oversee study targets, develop timelines, communication, risk, and quality plans, and provide team training and oversight.
• Schedule, plan for, and document regularly scheduled project team meetings. Assess project issues, propose resolutions, and track implementation of resolution through to completion.
• Ensure overall quality of project services and deliverables by documenting project/clinical trial progress to ensure completeness of documentation and data collection, management of supplies and resources in adherence with project timelines, budgets, and quality standards.
• Communicate status of studies regularly with the study team and management, escalating unresolved issues appropriately.
• Maintain the Trial Master File (TMF).
• Prepare site agreements, contracts, and track financial/site payments during study conduct.
• Develop protocols in conjunction with the Chief Operating Officer and Investigators.
• Attend and contribute to Investigator meetings.
• Ensure site and outsourced CRO staff are trained in protocol-specific procedures.
• Manage ethics, regulatory requirements, and local applications.
• Liaise with external customers e.g. Steering Committees, Investigators, Study Nurses, and Clinical Trial Pharmacists.
• Provide day-to-day operational management of CROs and vendors ensuring delivery against contracted scope of work for the allocated region.
• Plan and manage study budget.
• Contribute to process improvement.
• Assist with training and preparation of training material for study support roles.

Desired Skills and Experience:

• Proven clinical trials project management and leadership experience.
• Life science or other relevant degree.
• Excellent project management skills.
• Excellent presentation, communication, and organizational skills.
• Good attention to detail.
• Excellent interpersonal skills and a good team player.
• Cost and financial oversight.
• Proven ability to develop and update working practices.
• Flexible and effective project management, communication, and negotiation skills.
• Ideally, experience overseeing outsourced CRO work.
• Ideally, a strong understanding of cardiovascular disease and treatment is helpful, but other therapeutic areas are valuable too.