DUTIES & RESPONSIBILITIES
The jobholder will perform the role of Trial Manager for a selection of clinical trials sponsored by the Client. They will be a senior member of the Trial Management/Monitoring Team and will have line management responsibility for the Clinical Trial Administrators and Clinical Trial Assistants. Responsibilities will include:
· Coordinate and lead a multifunctional trial team to ensure that key trial objectives are delivered to agreed timelines and budgets.
· Ensure that trials are performed in accordance with ICH GCP, The Declaration of Helsinki and the appropriate local regulations and guidelines.
· Prepare clinical trial protocols and associated clinical trial documentation.
· Liaise with key opinion leaders and potential investigators regarding the clients clinical development plans and potential clinical trial designs.
· Prepare budget projections and resource requirements for clinical trials.
· Select and manage external Contract Research Organizations and suppliers.
· Train and mentor Clinical Research Associates, Clinical Trial Administrators and Clinical Trial Assistants.
· Act as Line Manager for Clinical Trial Administrators and Clinical Trial Assistants.
· Ensure that trial non-conformities are identified and ensure these are dealt with appropriately, both internally and externally.
· Assist in the training of contracted and site staff in ICH / GCP guidelines, and trial or the clients related processes and procedures.
· Maintain an up-to-date knowledge of the therapeutic areas at which the clients clinical development plans are aimed.
· Assist in the updating and maintenance of the SOP system to ensure maintained compliance with GCP and regulatory guidelines and legislation, and improve department effectiveness.
In addition to the above, employees may carry out any reasonable additional duties as reasonably required within the scope of the job title, and must work safely at all times with due regard for health, safety and environmental protection.
PRIOR EXPERIENCE & PERSONAL TRAITS:
This is a role for an experienced clinical research professional; a minimum of 5 years experience in clinical research is likely to be required to effectively carry out this role.
Essential Experience, Qualifications, Attributes:
Previous experience of working as a Senior CRA or Project Manager in multicentre, international clinical trials is essential. Working for a variety of companies is an advantage, as is experience in a variety of therapeutic areas.
Candidates should be life science graduates or qualified nurses, with a further post-graduate qualification in clinical research an advantage.
Personal qualities, skills and attributes must include the following:
· Excellent knowledge of the clinical trial process and drug development process
· Proven team leader
· Good attention to detail
· Ability to work to deadlines
· Excellent knowledge of ICH GCP and the applicable regulations/guidelines
· Ability and willingness to establish and maintain professional relationships at all levels
· Flexibility and adaptability to a fast paced environment
· Pro-activity, flexibility and self motivation
· Excellent time management and personal organisation skills
· Excellent communication and influencing skills
· Ability to mentor, motivate and manage staff
· IT literacy, particularly in Word, Excel and PowerPoint
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Contact
Andrew Bott
 on 08712 770 851 |
