Our client conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methods. The end goal of their clinical trials is to potentially eradicate common illnesses like the common cold and flu completely – or at least make treatment of them as easy and effective as possible. Volunteers are central to the work that we do. Studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
The Clinical Study Lead is responsible for providing site project coordination of all activities associated with clinical studies covering all phases from screening to follow up.
The CSL will work closely with key stakeholders, serving as the local site representative at project team meetings, and collecting and reporting information on site-specific study progress back to Project Management for dissemination internally and externally to sponsors. The CSL serves as the clinical site protocol expert, providing direction and guidance to clinical staff.
- Serve as central point of contact within Clinical Site for all study related questions, correspondence and information. Represents Clinical Site at all Study team meetings (including sponsor initiative visits, kick off and lessons learned meetings);
- Assist the Site Leadership Team with the clinical and logistical evaluation of proposed clinical trials, feeding back to the study design team with key input, feedback and ideas;
- Lead and coordinate the development and content of study specific training. Ensure appropriate approval is obtained and training is provided to and documented for applicable staff;
- Oversee completion of site specific project related documentation (i.e., delegation logs, Financial Disclosures, etc.), ensuring adequate and accurate study administration work processes are in place at site;
- Ensure that documentation is prepared within deadlines and filed appropriately within the site ISF.
- Monitor study progress to ensure compliance with and adherence to both the central and site project plan and to identify, evaluate and rectify problems;
- Provide guidance and mentoring to staff in the clinical environment, ensuring competence in performing their own and team’s daily tasks;
- Involvement in preparation, planning and execution of study related clinical activities;
- Develop and/or review and complete study related documents e.g. Standard Operating Procedures (SOP), logs, source data and CRF’s;
- Promote and adhere to Company SOP’s, protocols and Health and Safety Regulations
Skills & Experiences
- University/college degree (life science preferred)
- Competencies and skills
- Demonstrable good organisational and time management skills
- Ability to influence colleagues within a matrix structure
- Ability to use a wide range of Microsoft Office packages at the advanced level
- Good interpersonal and communication skills and ability to adjust communication to different target groups
- Good knowledge of ICH GCP & regulatory standards
- Good understanding of safeguarding confidential information required
- Skilful in creating and delivering technical clinical research skills training based on the study delivery needs
- Consultative approach, ability to advise on most suitable approach to deliver the study
- Demonstrated broad working experience in clinical research setting
- Extensive previous study coordination experience within Clinical Research
- Experience demonstrating the ability to work with minimal supervision and the ability to prioritize and organize work is required
A good understanding of the drug development process and previous line management experience is also desireable
For more information or to apply, please send your CV to David@SeltekConsultants.co.uk