Site Activation/ Study Start-Up Specialist

vor 2 Monaten

Zug, Zug, Schweiz Proclinical Staffing Vollzeit

Site Activation/ Study Start-Up Specialist
Salary: Swiss Franc50 - Swiss Franc57.50 per hour
  1. Job type:

    Contract
  2. Discipline:

    Project/Study Manager (CSM/CPM)
  3. Location:

    Switzerland
Zug, Schweiz
Posting date:
16 Jul 2024
Reference: 61396
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Proclinical are working with an established global company seeking a dedicated Site Activation Specialist to join a Clinical Operations team. This role is responsible for site start-up activities for assigned studies, working closely with various stakeholders including Contracting, Legal, Privacy, Study Teams, CRO, and Sites. The successful candidate must have flexibility in working hours along with fluency in English in order to support a multinational team. This position is on a 1 year rolling contract and holds a hybrid working model with 2-3 days required in the Zug office.

Responsibilities:

  • Oversee site activation deliverables across all regions for assigned projects.
  • Support pre-study site identification and selection process through collection and analysis of site feasibility information.
  • Maintain regular communications with investigational sites and CROs to ensure timely completion of site activation activities/documentation.
  • Coordinate Investigator Review Board (IRB)/ Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams.
  • Facilitate the translation of essential documents for submission to and approval from Competent Authorities and/or IRB/EC.
  • Support contract and budget negotiations in partnership with Contracting and Study Teams.
  • Support study instrument placements and obtain import/export licensure.
  • Collect and maintain relevant regulatory intelligence for future use.
  • Work closely with Study Teams to deliver study start-up tasks.
  • Support internal audit and external inspection activities; contribute to CAPAs as required.

Key Skills and Requirements:

  • Associate or Bachelor's degree in chemistry, biology, other life sciences, or a related field.
  • Experience in study start-up.
  • Knowledge of clinical trial methodologies, medical terminology, ICH/GCP.
  • Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations).
  • Ability to organise tasks, time, and priorities, ability to multi-task.
  • Must be fluent in English, and any additional language is a plus.

If you are having difficulty in applying or if you have any questions, please contact Jack Wingrove on

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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