Steve Lord is recruiting for an Interim Senior Clinical Project Manager to join a world leading research organisation at their offices in Central London. This position is a maternity cover as a fixed term contract of 15 months.
- Implementation, control and evaluation of assigned clinical projects through day to day operational managements
- Overall responsibility for successful delivery of clinical trials conducted in the UK and EU, including oversight of third-party vendors
- Development of clear and measurable project management plans in conjunction with the Head of Clinical Development, Project Management and Sponsor representative(s)
- Monitoring trial progress to ensure compliance with and adherence to project plans and to identify, evaluate and rectify any problems
- Design and implementation of site selection, monitoring (in-house and contracted) and recruitment plans
- Preparation and review of protocols, CRFs and informed consent documents as well as other essential documents required to run clinical trials
- Manage study budgets, contract negotiations and oversight of clinical vendors
-Responsible for TMF management and to ensure studies are inspection ready and regulatory compliant
- Lead and facilitate a clinical project team of in-house staff, external collaborators and/or clients
- Responsible for the cross-functional team's compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice GCP and ICH guidelines and other applicable regulations.
- Develop and oversee systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management
- Navigate and network within the NHS structure for trial approvals, contract negotiations and at sites
- Review monitoring reports and advise on how to resolve questions that arise at sites or escalate issues in a timely and appropriate manner
- Establish strong relationships at sites and with service providers with training of investigator staff, project team and vendors
- Accountable for development, oversight, and delivery of project team training
- Determines what project processes are needed, train and maintain project team knowledge/application of project processes
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree qualified within Life sciences
- 4 years of clinical project management experience, with at least 2 years of EU multi-national trials experience
- 7+ years experience overall in clinical research to including clinical monitoring or relevant medical/scientific experience
- Ideally experience of the NHS clinical trial set up and structure in the UK
- Experience within small /start-up organisation would be beneficial
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 45394 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Stephen Lord
- Phone: 01246 457722
- Reference: 45394
- Posted: 2nd May 2019
- Expires: 30th May 2019