This is an exciting role for a Clinical Project Manager to join a dynamic Clinical Applications team at Invicro in London.
The Clinical Project Manager will manage (including the administration, maintenance and coordination of) the logistical aspects of clinical studies at Invicro conducted in compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and relevant Standard Operating Procedures (SOPs).
The successful candidate will:
- Independently manage various study projects, programs simultaneously at Invicro from set-up through to close out to be conducted in compliance with the protocol, ICH GCP, GMP, SOP’s IRB/ethics committee and regulatory authorities’ requirements.
- Participate in the review and compilation of documentation for submission to Ethics, ARSAC and regulatory agencies.
- Participate in the completion of project agreements, clinical study contracts and CRO work orders.
- Responsible for managing project specific financials (revrec, change orders, budgets)
- Participate in meetings with investigative sites, key opinion leaders and consultants as needed.
- Assesses the operational feasibility of studies and recommends execution and risk mitigation plans.
- Manage Invicro’s project tracking tools to ensure that information is accurate and current.
- Serve as back-up to project managers and take on individual project assignments as necessary to support the business
The successful candidate will have:
- A degree or equivalent qualification in health sciences, nursing or pharmacy or related field
- Direct experience and in depth understanding of requirements for conducting clinical studies within early phase clinical drug development, including issues required to support data for human experiments, study design, study conduct, regulatory, technical and logistical issues.
- Experience of setting up clinical trials to ICH GCP, preferably obtained in industry, managing the execution phases as well tracking progress.
- Advanced level MS Excel, PowerPoint, Word; minimum of intermediate rest of MS Office suite.
- Good problem solving skills
- Excellent attention to detail
- The ability to work well under pressure
- Excellent team working skills
- To apply for this position please forward your CV and a covering letter detailing your relevant experience to HR at firstname.lastname@example.org.
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Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.
Imanova Limited, company registered in England and Wales, with registration number 07516277, trading as Invicro.