Providing Flexible Resourcing Solutions
Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.
An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.
Senior Clinical Safety Specialist
Our Client is an innovative R&D Biotech that has many agents at various trial phases and successfully achieved FDA Approval in 2015 for a new medical device within Oncology. They have a start up feel about them which creates a fast-paced, highly dynamic and entrepreneurial culture with an emphasis on being patient centric. They went “live” in 2015, so they are still setting and building up the structures and processes and are now in a role out phase for their new product. They are looking for a Senior Clinical Safety Specialist for a permanent position to be based in the Lucerne area.
The ideal candidate should have a minimum of 5+ years of active clinical experience or previous medical device/ drug related experience in multinational clinical trials.
As a Clinical Safety Specialist, you are responsible to implement and oversee all areas of safety monitoring and reporting for clinical trials.
- Process, assess and critically review adverse event data;
- Ensure proper maintenance of safety report database;
- Prepare periodic safety reports;
- Respond to Regulatory safety queries;
- Interface with Contract Research Organizations (CROs), project team members and clinical trial sites;
- Provide sponsor oversight of SAE processing by outsourced vendors;
- Train others on safety related topics internally and externally;
- Support the development/review of safety management plans and other relevant documents for the clinical trials;
- Support the set up and running of Data Monitoring Committees for clinical trials;
- Ensure activities comply with the applicable Quality System requirements.
- Minimum Bachelor’s level degree preferably in nursing, pharmacy or other health related profession or scientific discipline, or professional degree such as Registered Nurse/Pharmacist/Physician;
- Minimum of 5 years of medical device/drug safety-related experience in multinational clinical trials;
- Experience with clinical research in oncology;
- Understanding of North America, Europe and Asia regulatory systems for clinical trials and safety reporting;
- Experience working per Good Clinical Practice;
- Must be highly self-motivated, pro-active and flexible with independent working style and good organizational skills;
- Excellent verbal and written communication skills;
- Proficiency with standard office skills, standard desktop computing programs and medical terminology;
- Excellent interpersonal skills and willingness to work in a team environment;
- Highly organized and demonstrates understanding of workflow prioritization;
- Fluency in English (verbal and written) required;
- Relevant working/residency permit or Swiss/EU-Citizenship required.