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Details

Clinical Trial Site Start-Up Manager


Reference:SCAWWJ-356347 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Trial Site Start-Up Manager
Our client, a growing biotech organisation are currently recruiting for a Clinical Trial Site Start-Up Manager to join their team on a permanent basis. As Clinical Trial Site Start-Up Manager, you will coordinate and implement the clinical operations activities relating to the start-up of new clinical trial sites for the organisation.


Responsibilities

  • Responsible for the assessment of potential clinical sites, site qualification, and setup and implementation of site training programs for clinical trials
  • Ensure potential clinical sites are well-equipped and staffed for execution of clinical trials
  • Training to ensure correct implementation of drug handling, administration & accountability
  • Training of staff at the site in how to prepare subjects for study drug administration, safely monitor & support adequate follow-up
  • Develop & provide operational input to the development of study documents, including study protocols and Investigator’s Brochure
  • Provides operational input into the selection of CRO/CRO partners and contract negotiation
  • Provides support to the Clinical Development Team
Requirements
  • Degree related to Life Sciences (e.g., psychology, nursing, psychotherapy, medical doctor)
  • Proven experience from clinical work with patients, ideally in a research setting
  • Experience of working with mood disorder patients is a benefit
  • Updated knowledge of ICH GCP requirements is a benefit
  • Self-driven and motivated team player
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Excellent written and verbal interpersonal communication, influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
  • Good organization and tracking skills, as well as attention to details
  • Mandatory fluent English (both oral and written) – other languages are an asset