Site Activation Specialist; m​/f​/d

Site Activation Specialist (m / f / d) – Study Start-up / CRO Management / Clinical Trial Planning / IRB / Ethics Committee / Clinical Trial Methodologies / Medical Methodologies / ICH / GCP / English

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

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 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.

• 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 elevate 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‑up.
• Support study instrument placements, obtain import / export licence.
• 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.

• 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; flexibility in working hours may be needed.
• Participate and work effectively with…