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Clinical Study Administrator

  • Job reference: 926581
  • Location: Leeds, West Yorkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Administration, Life Sciences
  • Date posted: 12/07/2019

Orion Group are looking for a Clinical Study Administrator for our multinational medical devices client based in the West Yorkshire area on an initial 12-month contract with the potential to extend.

Job Purpose
This individual will provide support to the clinical study staff within the Clinical R&D COE, as well as fostering strong, productive relationships with colleagues within the Clinical R&D COE organization. Responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required. Supports project managers within the assigned clinical studies.

Main Responsibilities of the role

  • Clinical Administration Tasks - (includes CTMS build and tracking, v-TMF build & upload)
  • Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions
  • Creation/distribution of regulatory binders & the wet-ink signed documents binder
  • Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File)
  • Respond to problems and assists in implementing corrective and preventive actions
  • Assist in providing internal communication of important clinical data and events
  • Support ongoing use of CTMS by maintaining and tracking relevant activities
  • Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role)
  • May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
  • May be asked to assist with Device tracking and ordering if required and if applicable
  • Assistance with logistics for Investigator meetings/expert panel meetings
  • Assistance with distribution of newsletter (create mailing list from CTMS and routing for internal approval)
  • Participates in process improvement activities related to CTMS/v-TMF within the department

Desired Experience and Background of the successful candidate

  • Minimum of a Bachelor's Degree is required
  • Previous clinical research experience a plus
  • Requires previous administrative support experience or equivalent for at least 1 year
  • Clinical/medical background a plus
  • Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point)
  • Written and verbal communication
  • Attention to details
  • Organizational skills

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.