Description
Clinical Research Study Leader- 6 month contract
Study management- Pharmaceutical- Hertfordshire- contract- Phase I & II- Budget- Planning- Studies- ICH GCP- tracking- Monitoring- Vendor- CRO
A fantastic opportunity has become available for a Clinical Research Study Leader to join a Top 10 Pharmaceutical company based in Hertfordshire. The company are looking for a professional who is able to provide leadership for one or more global Study Management Teams responsible fore delivering internally managed and outsourced studies.
As a Clinical Research Study Leader you will:
* Responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting
*Prepares and manages the budget/financial plan including overall study and site-level costs
*ensures the development of study protocols in conjunction with SMT members
*Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management
*Proactive management of all aspects of the study
*Manages both internal and external partners
*contributes to CRO selection activities and contract set-up
*Assures consistency and standards across a study or studies for all investigational sites and in line with project standards
*Ensures that all adverse events are documented and that serious adverse events are processed and reported
*planning, tracking and managing the operational budget
An ideal Clinical Research Study Leader will have:
*Biomedical or Life Sciences Degree
*Study Management experience in Clinical or Pharmaceutical development
*Working knowledge of international regulatory and ICH GCP guidelines
*Experience in leady Phase I and Phase II studies
*Experience in more than one therapeutic area
*Prior management and mentoring experience
This is a fantastic opportunity for a Study Leader to gain experience in a Top 10 Pharmaceutical company for a 6 month contract with the possibility of extension.
If you are interested in this opportunity and wish to discuss further details about the role or other positions in the UK and Europe, please contact Sabrina Deo at +44 (0)121 616 3471.
Keywords:
Clinical, research, study, trial, study, manage, monitor, phase, ICH, GCP, Pharmaceutical, UK, London, Hertfordshire, budget, finance, SMT, vendor, protocols, biosample, CRO, partners, planning, tracking, adverse events, regulatory
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