Clinical Study Specialist

3 weeks ago

Uxbridge, United Kingdom Proclinical Staffing Full time

Proclinical is seeking four Contract Clinical Study Specialists for a large pharmaceutical company based in London. This role offers flexible working and the potential for a permanent position after a 12-month rolling contract. The Contract Clinical Study Specialist provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The role may involve supporting one or more studies across a program and may include both internally sourced studies and studies outsourced to Clinical Research Organizations (CROs).

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

  • Organize and deliver analysable reports and metrics to the clinical study lead.
  • Schedule and coordinate meetings, prepare agendas, presentation materials, and minutes for clinical study team meetings and other study-related meetings.
  • Collate data for assessments such as feasibility and site selection and review site usability database.
  • Contribute to the review of study documents such as informed consent forms, case report forms, and facilitate study document reviews per company standard operating procedures.
  • Compile study manuals including but not limited to: study reference binders and manuals and maintain versioning of study reference materials.
  • Track site activation, enrolment, and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from the monitoring plan.
  • Monitor and update investigator/site status for the trial, and support with clinical trial registry postings.
  • Perform scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance.
  • Manage and maintain team SharePoint and/or shared drive sites, as needed.
  • Communicate with sites as directed and maintain site contact information.
  • Contribute to line listings review for Blind Data Review Meeting (BDRM).
  • May manage or contribute to oversight of Third Party Vendors (TPV).
  • Track and monitor close-out activities - study close-out documents and CRA close-out visits.
  • Participate in Standard Operating Procedures (SOPs) revisions or departmental initiatives.
  • Proactively recommend process improvement initiatives for the department.

Key Skills and Requirements:

  • Strong organizational skills.
  • Excellent communication skills.
  • Ability to manage multiple tasks and projects simultaneously.
  • Knowledge of clinical trial processes and procedures.
  • Familiarity with SharePoint and/or shared drive sites.


If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at m.pike@proclinical.com



Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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