ProClinical is currently seeking a Senior Clinical Manager for a leading biopharmaceutical company. The purpose of this role is to ensure the planning, implement and monitoring of the progress of clinical trials and to be responsible for the overall day-day operational management either sponsored by the client or on behalf of its partners.
- Responsible for implementation, control and evaluation of assigned clinical projects undertaken by the client through day to day operational management
- Overall responsibility for successful delivery of clinical trials conducted in the UK and EU, including oversight of 3 rd party vendors
- Development of clear and measurable project management plans in conjunction with the Head of Clinical Operations, 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 the company’s clients
- Responsible for the cross-functional team's compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) / International Conference on Harmonization (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.
- Establishes and communicates team performance expectations and guidelines.
- Establishes strong relationships with the company’s clients and acts on behalf of the Head of Clinical Operations
- To be proactive in looking for opportunities to accelerate the clinical trial process within the UK
- Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intra-departmental procedures and other continuous process improvements programs, as assigned.
- Up to 20% travel will be required within the UK with potential for some EU travel
Skills and Requirements:
- Minimum 4 years of clinical project management experience, with at least 2 years of EU multi-national trials experience, or appropriate applicable experience.
- 7+ years strong clinical research background, including clinical monitoring with medical and/or scientific experience preferred.
- Experience working with or in the NHS clinical trial structure in the UK would be advantageous
- Experience of working within a small and / or start-up organisation would be advantageous
- Experience of working with novel therapies or novel approaches in study conduct and flexibility would be advantageous
- Familiar with the UK regulatory environment and NHS operational requirements
- Familiar with the detail of GCP regulation
- Experienced in managing a varied and complex workload
- Highly pragmatic and practical, whilst motivated to ensure that studies meet challenging timelines
- Able to quickly find practical, compromise solutions to problems and propose options for resolution to the Head of Clinical Operations
- Excellent interpersonal, verbal and written communication skills (including experience in making presentations)
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives
- A good team player.
- Educated to degree level within Life Sciences (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification / experience
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.