Site Activation Specialist

vor 2 Wochen

Rotkreuz, Zug, Schweiz Itech Consult Vollzeit CHF 60'000 - CHF 90'000 pro Jahr

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

____________________________________________________________________________________

Reference Nr.: 924558

Rolle : Site Activation Specialist (m/f/d)

Industry: Pharma

Location: Rotkreuz

Pensum: 100%

Start: Startdatum:

Duration: 12+ Monate

Deadline: 13/11/2025

Job Type: 100%

Work Location: On the road

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