6 days ago

Clinical Research Study Leader- 12 month contract

Welwyn Hatfield Competitive Contract

Job Reference: 162536

Clinical Research Study Leader- 12 month contract

A fantastic opportunity has become available for a Clinical Research Study Leader to join a Top Pharmaceutical company based in Hertfordshire on a 12-month contract.
  
*They offer flexible working but you must be able to travel to the office for meetings.*
  
The company is looking for a professional who is able to provide leadership for one or more global Study Management Teams responsible for delivering internally managed and outsourced studies. This position will be working across their focus areas; oncology, neuroscience, infectious diseases, inflammation, ophthalmology or rare diseases.

  
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 leading Phase I and Phase II studies
  • Experience in more than one therapeutic area listed above
  • Prior management and mentoring experience

This is an urgent role for the company so if you are interested in this opportunity and wish to discuss further details about the role, please contact Sabrina Deo at sdeo@pararecruit.com
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