Beschreibung
DRA Clinical Trial Manager (m/f/d)
Reference: -en
Start: asap
Duration: 8 MM++
Main tasks:
- Tasks related to Clinical Trial Applications (CTAs):
- Interact with internal departments or teams, affiliates and third parties 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, affiliate and/or CRO 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 End of Trial notifications, Clinical Study Report synopsis, answers to HA questions, 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
- Maintain 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):
- 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 forwarding copies of relevant documentation in a timely manner
- Other tasks:
- 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
Main 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
- 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
Main advantages:
- Good infrastructure
- Pleasant working atmosphere
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Dominic Yves Peter
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