The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a:
Drug Regulatory Affairs Clinical Trial Manager 100% – 5716 LBD
10-month contract based in Basel area with possibility for extension.
Tasks related to Clinical Trial Applications (CTAs):
- Interact with internal departments or teams and third parties (e.g. External Service Providers [ESPs]) as required to give regulatory input and guidance for clinical trials and their submission to European and international Health Authorities (HAs).
- Prepare, submit and maintain CTAs to European and international HAs in accordance with the applicable regulatory requirements.
- Liaise with internal, regional and/or ESP personnel to request and collect appropriate documents and, where applicable, to arrange submission.
- Interact with HAs and/or other parties regarding CTAs.
- Ensure proper running of the trial during its life cycle from a regulatory perspective.
- Ensure that timelines are met for submissions such as answers to HA questions, End of Trial notifications, Clinical Study Report synopsis, etc.
- Maintain tracking sheets listing submission and approval dates per country for initial CTA, amendments,
- End of Trial notifications and submission of Clinical Study Report synopsis.
Tasks related to the Clinical Trial Team (CTT):
- Attend and contribute to CTT meetings, providing regulatory updates and information as required.
- Discuss country timelines and prioritize submissions in conjunction with relevant CTT members.
- Provide advice to CTT members on HA CTA submission processes and other related submissions, such as amendments, End of Trial notifications, etc.
- Keep the relevant CTT members informed of the status of HA-related matters, including providing relevant documentation in a timely manner
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- Previous experience in preparing, submitting and maintaining Clinical Trial Applications to European and International Health Authorities in accordance with the applicable regulatory requirements
- Thorough understanding of the regulatory requirements applicable for submission and maintenance of CTAs in and outside of Europe (e.g., Clinical Trial Directive, Clinical Trials Regulation, etc.)
- Excellent organizational, interpersonal, and communications skills, together with meticulous attention to detail
- Ability to work efficiently and effectively to tight deadlines
- Excellent spoken and written English (knowledge of another European language would be an advantage
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.