Clinical Operations Project Manager - Home Based
Steve Lord of CK Clinical is recruiting for a Clinical Operations Project Manager to join a Global Biopharmaceutical company, in a home based role, on a full time permanent basis. Our Client is a fast growing specialist biotech company who are leading the development of treatments for Chronic Endocrine Conditions, on an international level.
The Clinical Operations Project Manager will report to the Head of Clinical Operations, whilst working closely with the Medical Director and assuming responsibility for the clinical project management of the Company's development programmes.
As a Clinical Operations Project Manager, you will have the following requirements and responsibilities:
- Clinical project management experience (including planning, implementation and execution) for the Company's key development programmes.
- Specifically, to manage clinical studies to ICH-CP standards, and current country legislation's in line with the Company's Sops.
- To manage or participate in the selection process for clinical CROs, vendors & consultants
- Liaison with all relevant departments and consultants including Regulatory, PV, CMC, Data management & Stats, Medical writing, medical monitoring, monitoring and finance.
- Track clinical study progress and report issues to head of clinical operations, global program team and 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, 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 the Chief Executive Officer may determine from time to time.
- Contribution to internal project team meetings with study updates and highlights.
As a Clinical Operations Project Manager, you will have the following qualifications, skills and experience:
- Prior experience running clinical trials and working in accordance with GCP; GVP (or other GXP areas) and current EU legislation.
- An overall understanding of drug development and the clinical trial process.
- Experience including reviewing and writing SOPs.
- Experience in the management of CROs and working within a remote working team.
- Comfortable with home-based working in a virtual company and able to travel to meetings in company offices in Cardiff and London and to other locations e.g. CRO if, and when, required.
- Knowledge and experience in clinical operations, current and trained in GCP, safety and regulatory procedures.
- Highly organised, able to work on own initiative, with excellent attention to detail, able to produce high quality work to agreed deadlines.
- Experienced in computer applications and business software. -Ability to be self-motivated and innovative.
For more information or to apply for Clinical Operations Project Manager position please contact Steve Lord on 01246 457738 or email email@example.com. Alternatively, please click on the link to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41903 in all correspondence.