Clinical Project Manager

3 weeks ago

London, United Kingdom Hays Specialist Recruitment Limited Full time

Experienced Early Phase Clinical Study Manager 12 month contract remote, good rate (in scope)

A Clinical Study Manager is required to join a global pharma on a contract basis. This is a 12 month fully remote position based in the UK. The contract will sit inside IR35.
Responsibilities will include:

- 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.
- At the study kick-off meeting, articulate study scope, goals, and expectations to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning.
- Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making. Such as for Safety Monitoring/DataMonitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings and final CSR.
- Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments. Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementationof activities by the CRO/Phase 1 Unit.
- Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.
- Engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.
- Understand, manage, track and ensure accuracy of study budgets, including the forecast and accrual information.
- For assigned studies, work closely with the respective Program Delivery Leads, and other team members and stakeholders as required, to serve as the key internal clinical operations contact whilst keeping the PDL updated on all study issues.

What you can bring to the role:

- Minimum Bachelors Degree in life sciences related discipline or related field
- Substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end
- Experience working within a remote working team and liaising with different vendors to achieve a common study goal
- Highly organised, able to work on own initiative, with excellent attention to detail, able to produce high quality work to agreed deadlines
- Willingness to travel - possibly globally - when required

What you get in return:

- The opportunity to work with a global pharmaceutical company
- A fully remote role
- Competitive rates of pay

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