DRA Clinical Trial Manager
Collaborate with colleagues coordinating and tracking eCTD submissions for EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed.
- Collaborate with colleagues coordinating and tracking eCTD submissions for EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed;
- As required, provide support to the Regional Management Group for national submissions according to regional guidance’s;
- Interacting with HAs and/or other parties regarding CTAs;
- Ensuring proper running of the trial during its life cycle from a regulatory perspective;
- Ensuring that timelines are met for submissions such as End of Trial notifications, Clinical Study Report synopsis, answers to HA questions;
- Maintaining tracking sheets listing submission and approval dates per country for initial CTA, amendments, End of Trial notifications and submission of Clinical Study Report synopsis;
- Maintaining the relevant sections of the Trial Master File for the duration of the clinical trial and prepare and QC the documentation before arranging final transfer.
Tasks related to the Clinical Trial Team (CTT):
- Attending and contributing 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.
- For applicable countries, liaise with internal, regional, affiliate and/or CRO 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 SOPs and processes;
- Final sign-off of IMP Shipment Approval requests for relevant departments;
- Keep country-specific information updated and inform other members of the CTA group accordingly.
Qualifications and Experience:
- 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;
- Committed attention to detail;
- Team spirit;
- The 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;
- Relevant working/residency permit or Swiss/EU-Citizenship required.