Start date: ASAP
Duration: 12 months
Workload: 100%
Site: Allschwil (Basel-Land)
Contractor Rate: CHF 77.96
Job Responsibilities
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.
Upload documents to the electronic Trial Master File (TMF) as required, 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.
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.
Candidate Requirements
At least two years' experience as a DRA Clinical Trial Manager or equivalent experience gained externally in a similar field.
Good organizational and communication skills.
Committed attention to detail.
Team spirit.
Ability to prioritize tasks and work to deadlines.
Customer oriented.
Excellent MS Office skills.
Excellent spoken and written English.
Knowledge of any other European language would be an advantage.
Please apply here and Harry Henson will be in touch to discuss your application further!
#J-18808-Ljbffr