Berufsbezeichnung: Clinical Trial Documentation Specialist

Arbeitsbeschreibung:
Sequana Medical (www.sequanamedical.com) is a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders. We are looking for a motivated person with analytical, research and planning skills to join our small and dynamic clinical team in Zurich as soon as possible.

Clinical Trial Documentation Specialist 80 - 100 %

We are offering you a one-year temporary work employment within a fast-paced environment. You will be based in Zurich office and need to be willing to travel to our Belgium office from time to time. You will report directly to the Director of Clinical Operations and being responsible to the clinical team in Belgium. In this role, one of your main responsibilities is to perform an ongoing quality control of Trial Master File and ensure its inspection readiness.


Key responsibilities:
-Trial and site administration: 1) Tracking (e.g. essential documents) and reporting, 2) Ensure collection of Essential Documents required from various sites and distribution of study tools and documents, 3) Update clinical trial databases, 4) Responsible for clinical supply & non-clinical supply management
-Document management: 1) Prepare study documents and ensure accuracy, 2) Collate, distribute, and archive clinical documents (i.e. TMF) follow up with the relevant functions until their resolution, Monitor the TMF quality issues 3) Updating manuals/documents (e.g., patient diaries, instructions), 4) Documentation of clinical supplies 5) Perform review of the TMF Management Plans
-Regulatory & Site Start-Up responsibilities: 1) Provide to and collect from investigators forms/lists for site evaluation/validation and site start-up, 2)  Preparation of Regulatory Agency and IRB/ERC submission packages (including supporting creation of local IC), other Regulatory Agency and IRB/ERC related activities. 3) Support the clinical study teams in the preparation, conduct and follow-up of internal and external audits/inspections.
-Budgeting: Collaborate with finance/budgeting representatives for: 1) tracking, and reporting of negotiations 2) contract development, approval  and maintenance, 3) payments (investigators, vendors, grants), 4) Monitor and track adherence and disclosures, 5) Budget closeout.
-Meeting Planning: 1) Organize and support local investigator meetings (materials and vendor support where applicable).


Key requirements:
-Excellent understanding of ICH GCP
-Strong experience with clinical trial processes and development
-Familiar with TMF, eTMF and e-CRF systems
-Excellent command in spoken and written English and German, every other language in addition is a plus
-Ability to deliver constant high quality of work
-IT literacy, proficiency with Microsoft office applications (Outlook, PowerPoint, Word,  Excel)
-Ability to work independently and in a team, in a fast paced setting
-Very good communicational skills and the ability to work within an international team
-Be able to start within 2 months
-Willing to work on a temporary one year contract


Required education and professional experience:
-MSc or BSc or equivalent in natural sciences
-GCP certification
-Experience with supporting clinical trials in Europe and North America
-Over 5 years experience with clinical trial administration
-Experience with international site management
-Work experience in both CRO and Sponsor setting


Have we piqued your interest? Then please send your complete application, we accept English as well as in German, to careers (at) sequanamedical.com. We are looking forward to meeting you personally!

Wie Sie sich bewerben:
katharina.haase (at) sequanamedical.com

Angestelltenname:
Sequana Medical NV, Ghent, Zweigniederlassung Zürich