Job Description

Project:

For our customer a big Diagnostic company in Rotkreuz, Zug we are looking for a qualified Site Activation Specialist (m/f/d)

Background:

The Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, CRO, and Sites.

The Perfect Candidate:

The ideal candidate possesses a Bachelor's degree in life sciences and extensive study start-up experience, including proficient knowledge of CRO management and global regulatory submissions (IRB/EC, Competent Authorities). They must have a strong working knowledge of ICH/GCP and global regulations like IVDR, coupled with the ability to organize and multi-task effectively to drive timely site activation deliverables across multiple regions. This individual is a fluent English speaker who excels at cross-functional collaboration, ensuring all regulatory documentation, contracts, and logistics are completed with attention to detail and quality.

Tasks & Responsibilities:

? Responsible for the effective operations and delivery of site activation deliverables across all regions, within the assigned projects.
? Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information.
? Maintain regular communications with investigational sites/CRO to ensure timely completion of the required site activation activities/documentation and resolve or escalate issues in a timely manner
? Collect, receive and perform the first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements
? Coordinate Investigator Review Board (IRB)/Ethics Committee (EC)/other relevant regulatory submissions in collaboration with sites/study teams
? Work with sites to ensure informed consent form meets the required regulatory and company requirements. ? Facilitate the translation of essential documents that may be required in languages other than English for the purposes of submission to and approval from Competent Authorities and/or IRB/EC.
? Coordinate the clinical trial insurance process to ensure timely results and support throughout the conduct of the clinical study.
? Support contract and budget negotiations in partnership with Contracting and Study Teams.
? Ensure Purchase orders and Fair Market Value assessments are completed for timely start-start up.
? Support study instrument placements, Obtain import/export licensure
? Support implementation and use of eTools at the site
? Collect and maintain relevant country, local, state, and site-level regulatory intelligence for future use
? Work closely with Study Teams to deliver study start-up tasks.
? Solve identified issues with appropriate timely escalation to the Study Teams
? Support internal audit and external inspection activities; contribute to CAPAs as required.
? May be responsible for other responsibilities as assigned.

Must Haves:

? Associate or Bachelor's degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience
? Experience in study start-up is required
? Experience with CRO management.
? Experience in clinical trial planning, including IRB/Ethics Committee, Competent authority submissions and contracts
? Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
? Must be fluent in English
? Working knowledge of global and local regulatory requirements (IVDR and other applicable regulations).
? Understand the quality expectations and emphasis on the right first time, attention to detail
? Ability to organize tasks, time, and priorities, ability to multi-task
? Required to support multi-national team members, and flexibility in working hours may be needed. ?Participate and work effectively with multiple cross-functional teams

Nice to haves:

?Any additional language
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Reference Nr.

: 924558

Rolle :

Site Activation Specialist (m/f/d)

Industry

: Pharma

Location:

Rotkreuz

Pensum:

100%

Start:

01.01.2026(Startdatum: 01.02.2026)

Duration:

12+ Monate

Deadline:

13/11/2025

Job Type: 100%

Work Location: On the road