Clinical Project Manager
- Experience Level
- Experienced (non-manager)
Michael Parker from Umbilical Life is recruiting a rare opportunity for a Clinical Project Manager.
The client is a privately-owned SME based in the midlands (Leicestershire) and has sustained continued growth over the last couple of years.
My client is successful as both a CDMO and manufacturing of their own products. However recently they also have a new business section which is clinical focused.
This role will have a start-up feel and really allow you to put your own stamp on the position. They have an exceptional pipeline and a lot of trials and new products to come.
The general overview of the role is to oversee, manage and be responsible for the execution of assigned clinical trials according to ICH-GCP, SOPs and all applicable regulations.
Some of the key responsibilities are:
- Ensure trials are carried out according to the study protocol, SOPs, ICH-GCP, regulations and trial-specific manuals and procedures.
- Design and writing of clinical trial documents including, but not limited to, protocols, project plans, site and patient facing materials.
- Arranging translation of patient facing materials and study documents as and when required.
- Develop and administer study budgets, tracking all contracts and scope of works until completion.
- Ensuring tracking of site payments and resolution of any issues relating to this.
- Participate in the selection of vendors and ensure that work is performed in accordance with scope of work.
- Co-ordination and review of any vendor or site contracts and invoices.
- Management and oversight of the conduct of the clinical trial through regular meetings with CRAs, the project team and all vendors including tracking of progress. Escalating issues or concerns to the Senior Clinical Project Manager, Head of Clinical Development and Head of Quality Assurance as appropriate.
- Coordinates all monitoring and audit activities of clinical sites/vendors for adherence to the protocol, GCP and regulatory requirements.
- Provides guidance, training and direction to contract CRAs in the field and in-house clinical staff.
- Submissions to ethics committees, competent authorities and any other required agencies.
- Review of monitoring visit reports to ensure compliance with the protocol, ICH-GCP, SOPs and applicable regulations.
- Ensures there are always enough trial supplies for the study (including IMP).
- Responsible for ensuring the release of IMP to site once all the necessary regulatory approvals and documentation are in place.
- Overall responsibility for the contents of the Trial Master File and ensuring that the documentation is of a high standard and inspection ready.
- Resolves patient eligibility and protocol deviations and reviews all on a periodic basis in case changes to the protocol are required.
- Participate in the development and review of SOPs pertaining to clinical trial activities.
- Identify suitable investigator sites through feasibility questionnaires and site evaluation visit reports and approve sites that meet the necessary criteria.
- Assists with review and writing of the clinical study report and annual safety reports.
- Assists with establishing and tracking clinical timelines and appropriate performance metrics.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with Head of Clinical and Regulatory, medical adviser, investigators.
- Ensuring appropriate archiving of the TMF once the study is complete, following company SOPs and regulatory requirements.
Please get in touch as soon as possible if of interest.
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