Site Activation Specialist (m/f/d)

As a first-tier supplier to our renowned business partner Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Site Activation Specialist for a temporary assignment of 12 month, with high probability of extension.

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
• Fluent in English, any additional language is a big plus
• 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

Benefits

• Work with state-of-the-art tools on a modern campus featuring green spaces and an inspiring atmosphere
• Experience a work culture that promotes diversity and inclusion, where everyone feels valued
• Benefit from financial support for your professional development and further education
• Take advantage of unbeatable, year-round discounts with renowned retailers, over 200 top brands, as well as fleet discounts on new car purchases and consistent fuel discounts
• Become part of one of the most renowned pharmaceutical companies and actively help shape the future of healthcare
• Enjoy a selection of high-quality meals in modern staff restaurants
• Where applicable, benefit from on-site parking as part of a sustainable mobility concept
• Start with professional onboarding and a thorough introduction to your new role during the Welcome Days
• We offer you a long-term position and diverse development opportunities within the company

Are you interested? Don't hesitate and submit your complete application documents online today. We look forward to hearing from you!

Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.

Kontakt
Kristof Wildmann

Arbeitsort
Rotkreuz

Pensum
100%

Position
Mitarbeiter

Branche
Projektleitung + Management