Contract Clinical / Senior Clinical Study Manager
ProClinical is seeking a Contract Clinical / Senior Clinical Study Manager for a small biotech company based in Hertfordshire, Uk on a 6 month rolling contract. 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.
- Responsible for implementation, control and evaluation of assigned clinical projects undertaken by the company through day to day operational management
- Overall responsibility for successful delivery of clinical trials conducted in the UK and EU, including oversight of 3rd 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
- 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.
- 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)
- Flexibility towards work assignments, new learning and travel
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail and excellent organizational skills
- Ability to work quickly and accurately, with limited supervision, good initiative taker when required
- Accurate with a strong focus on attention to detail
- Keeps up to date with professional knowledge, expertise a