Clinical Operations Project Manager
- Reference: JLSCOPM
- Location: Home Based
- Salary: Upto£55000
- Type: Full time
- Start: asap
- Duration: 12 Month Contract
Just Life Sciences are working with an award winning and globally expanding Pharma business who are experts in their chosen field, they have a fantastic opportunity for a Home Based Clinical Operations Project Manager to join them on a 12 month Contract
You will have prior experience of
running Clinical Trials, in accordance to GCP, GVP and EU Regulations,
have an understanding of Drug Development and the Clinical Trial process,
Qualifications, Skills and Experience
If successful you will
- Manage clinical studies to ICH-GCP standards, current local country legislations and in line with company’s SOPs.
• Manage and/or participate in the selection process for clinical CROs / vendors / consultants in line with the company Vendor selection process.
• Liaison with all relevant departments and consultants to the Group, including but not limited to Regulatory; PV; CMC; Data Management and Statistics; Medical Writing; Medical Monitoring; Monitoring; Finance.
• Manage selected Clinical CRO’s; vendors and consultants and their conduct of Group’s clinical studies acting as their single point of contact.
• Track clinical study progress and report any issues to the Head of Clinical Operations, Global Program Team and the Medical Director.
• Ensure all clinical study activities are performed to the highest standards, to budget and within agreed timelines.
• Ensure sufficient resources are available to manage and monitor the Company’s studies.
• Organisation and planning of study-related meetings; ensure written records are kept including all key decisions.
• Co-ordinate the supply of study medication including facilitating the forecast, distribution, returns and destructions of such material.
• Ensure accuracy and consistency in protocol and CRF design, data management processes and related study specific documentation.
• Assist in the preparation and review of study protocols and other study specific documentation.
• Management of CRAs for internally run clinical studies; review and approve clinical monitoring plans and co-ordinate monitoring of clinical studies in accordance with approved clinical monitoring plans.
• Work with the CTA team and support the maintenance and review of study TMFs (both paper and electronic).
• Coordination of contracts for Investigator sites; vendors and consultants to the Group, liaising with the finance department during the process. Periodic review of contracts to endure they remain current and within scope.
• Assist in the writing, compilation and/or review of clinical SOPs; to maintain an understanding of the external environment for conducting clinical research in Europe.
• To comply with such instructions in connection with the business of the Company as the Head of Clinical Operations, Medical Director or Chief Executive Officer may determine from time to time.
• Contribution to internal project team meetings with study updates and highlights. Continual Improvement, support of the QMS, CAPA and Training
• Responsible for ensuring that the business is driven by continual improvement in Quality
- If you have the above experience and can commit to a 12 month contract, which maybe extended, then please email your CV to justyn at justlifesciences dot com
Just Life Sciences
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