Contract Clinical / Senior Clinical Study Manager

400.00 - 500.00 GBP Daily
30 Sep 2017
28 Oct 2017
Contract Type
Full Time

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.

Job Responsibilities:

  • 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