Clinical Site Activation Specialist
vor 2 Wochen
CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.
Our client is a leading Swiss multinational healthcare company headquartered in Basel, Switzerland. Operating in Pharmaceuticals and Diagnostics, it is one of the world's largest biotech companies and a global leader in in-vitro diagnostics and cancer treatments. Our client is known for its strong focus on innovation, particularly in personalized healthcare, and has played a major role in developing treatments for oncology, immunology, infectious diseases, and neuroscience.
For their office in the area of
Zug
, Switzerland, we are currently looking for a:
Clinical Site Activation Specialist
offering an initial contract of 12 months with high chances of extension to an unlimited contract to be based in the area of Zug.
Main Responsibilities:
- Delivering site activation deliverables across all regions, within the assigned projects;
- Supporting pre-study site identification and selection processes;
- Assisting in contract and budget negotiations in partnership with Contracting and Study Teams;
- Maintaining regular communications with investigational sites and Clinical Research Organizations to ensure timely completion of the required site activation activities;
- Collecting and performing the first review of required study-specific site regulatory and other essential documents in accordance with applicable SOPs, guidelines, and study timelines and requirements;
- Coordinating Investigator Review Board (IRB), Ethics Committee (EC) and other relevant regulatory submissions in collaboration with sites and study teams;
- Working with sites to ensure informed consent form meets the required regulatory and company requirements;
- Supporting internal audit and external inspection activities and contributing to CAPAs as required.
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required.
- At least a Bachelor's degree in a scientific subject (no PhD).
- Experience in study start-up as clinical research associates.
- Experience with CRO management.
- Working knowledge of global and local regulatory requirements including - IVDR for Medical Devices is a big plus.
- Having supported 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, German would be preferred.
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.
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