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(Senior) DRA Clinical Trial Manager, Basel
Client: CTC
Location: Basel
Job Category: Other
Job Reference:
81950e947ae3
Job Views:
3
Posted:
13.04.2025
Expiry Date:
28.05.2025
Job Description:
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.
For our client, a leading International biopharmaceutical company with an important innovation hub in Basel, Switzerland, we are looking for a
(Senior) Drug Regulatory Affairs Clinical Trial Manager (6467)
for a 12-month contract initially, extension possible.
…related to Clinical Trial Applications (CTAs):
* Interact with internal departments/teams and 3rd parties (e.g. External Service Providers) 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 company internal, regional and/or ESP personnel to request and collect appropriate documents and 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.
* Upload documents to the electronic Trial Master File (TMF) and/or maintain the relevant sections of the paper TMF for the duration of the clinical trial and prepare and QC the documentation before arranging final transfer for archiving.
…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.
…other tasks:
* For applicable countries, liaise with company internal, regional and/or ESP personnel to manage submissions related to import/export licenses, including following-up on status of submission and providing input to tracking sheets.
* Contribute to update of existing and creation of new internal Standard Operating Procedures (SOPs) and processes.
* Keep country-specific information updated and share experience and lessons learned with other members of the CTA group accordingly.
The Drug Regulatory Affairs Clinical Trial Manager will report to a Global Regulatory Operations Group Leader.
Qualifications:
* A scientific background or working experience in Clinical Trials in Europe/Rest of World or in the pharmaceutical industry would be an advantage.
* Good organizational and communication skills and committed attention to detail.
* Team spirit.
* Ability to prioritize tasks and work to deadlines.
* Customer oriented.
* Excellent spoken and written English, any other European language would be an advantage.
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