Job Ref: 215433686

Date: 2021-12-23 11:42:05

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Hobson Prior are seeking a Clinical Project Manager to join a CRO Consultancy organisation who are focused on orphan product candidates supported by a team of specialists in the field of rare diseases.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

Conduct Handover Meeting from Business Development to the clinical team ensuring all relevant parties are included and informed of every aspect of the trial, including their FTE and allocated budget.
Select suitable Clinical Study Team members conducting interviews where necessary.
Conduct a Kick Off meeting with the Sponsor and the study team and meetings with the internal team, Partners and Vendors as required.
Establish roles and responsibilities, budget and invoicing practices.
Prepare key project management documentation, e.g. Project Plan, Communication Plan etc., in line with Client requirements.
Organise and/or participate in Sponsor/Project team/Investigator meetings.
Ensure contracting parties are aware of any operational changes that may impact the study.
Ensure process is defined with the sponsor regarding out of scope work.
Assist Business Development with Scope of Work and Budget completion, defining tasks and resource requirements
Participate in Bid Defence meetings.
Assess study resource and changes to ensure adequate levels to conduct study activities agreed at the current study contract.
Participate in the development/review and maintenance of all study related documents, templates, plans, manuals, Trial Master File and site investigator files.
Perform Regulatory and Ethics co-ordination, ensuring QC of all packages and sending to Sponsor
Work with team members on the preparation of packages (Competent Authorities, central and local Ethic Committees/Independent Review Board) submission, responses to gain approval.
Establish communication channels to the study team, sponsor and vendor teams within Scope of Work.
Develop a communication plan where applicable.
Any other assigned duties.Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy

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