Based in London Bridge SE1, a short walk from the main railway station, this is an excellent permanent opportunity for an experienced Clinical Project Manager / Clinical Study Manager. If you would relish conceiving and managing studies involving advanced cell and gene technologies delivering life changing solutions to multiple therapeutic areas then please read on…………
The organisation was established in 2012 as an independent centre of excellence to lead the growth of the UK cell and gene therapy sector. Bridging the gap between scientific research and commercialisation, the company now has more than 120 employees working internationally. Partners include organisations in academia, the pharma industry and health services collaboratively facilitating life-changing therapy developments for use globally.
The company’s vision is to make the UK the immediate and logical choice for partners to develop and commercialise advanced innovative therapies.
The purpose of this role is to manage the conception, planning, implementation, monitoring and delivery of clinical trials with responsibility for the overall operational management. Studies will be either sponsored by the company or conducted on behalf of partners. This is a broad and collaborative position with accountability for the successful conclusion of clinical trials conducted in the UK and EU.
The role will encompass:
- The development of clear and measurable study project management plans in conjunction with internal and sponsor representatives.
- Forming, leading and facilitating the clinical project team of internal staff, external collaborators and / or clients including identifying and addressing training needs.
- The design and implementation of site selection, patient recruitment strategies and monitoring (in-house and contracted).
- Preparation and review of protocols and all essential study documentation including management of the TMF.
- Maintaining a status for regulatory compliance and audit inspection readiness at all times.
- Management and accountability for contract negotiations, study budgets and third-party vendor performance.
Full company details and job description will be provided to appropriate candidates on application for the role and receipt of their CV details.
The company is offering this permanent role with a salary to £68,000 backed by a substantial benefits package which includes PHI, contributory pension to 15% of salary (10% company, 5% employee), performance related 5% annual bonus, childcare / eyecare vouchers, interest free travel loan and cycle to work scheme. Added to this is an annual pay review in addition to a cost of living salary rise.
Of equal importance, the company provide a structured on-boarding process with a mutually agreed training and development investment plan plus achievement milestones that will be recognised and rewarded.
Desired Skills and Experience
We are seeking a dynamic yet pragmatic and practical individual motivated to conceive, lead and deliver challenging studies within budgets and timelines. We require a minimum of 4 years clinical project management / leadership experience, which will include EU multi-national trials. This will be backed by a strong clinical background (typically CRA), including monitoring. Experience of working with, or in, the NHS clinical trial structure would be advantageous as would experience of working within a small or start-up organisation. Any experience of working with novel, personalised / patient specific or oncology solutions would be beneficial.
Excellent interpersonal, verbal and written communication skills and the ability form relationships at all levels is mandatory.