2 freie Stellen /
Vollzeit / deutschlandweit / 1 Jahr mit Option auf Verlängerung / ab sofort
Stellenangebot: Chiltern International
Unser Unternehmen
Established in 1982, Chiltern is a leading global Contract Research Organization with extensive experience of in conducting and staffing global Phase I to Phase IV clinical trials across a broad therapeutic range.
We provide product development services to the pharmaceutical, biotech and device industries including Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions.
By understanding our customers needs for timely and accurate results we aim to exceed rather than simply meet their expectations. Our commitment to quality and service-led relationships is evident in our high rate of repeat and referral business and in our high levels of staff retention.
Ihre Aufgaben
For one of our clients, a pharma company near Cologne, we are looking for two
Clinical Trial Assistants (m/f) Ref. 4736
to work in our client`s office. One position is fulltime and one position part-time (20hours per week). Both vacancies are limited to one year with the option of extension Freelancers are also welcome!
Responsibilities
- Assist the clinical trial team to manage trials efficiently to the required regulatory standards, especially with document management and tracking (including the CTMS system), including set-up and maintenance of all sections of the Trial Master Files (Core Files, Country Files, Sites Files).
- Create and maintain designated trial tracking tools in accordance with trial requirements (e.g. Essential Documents, Site and Vendor Activities, Monitoring Visit Reports, Trial Budget)
- Prepare, distribute and file agenda, minutes and meeting materials as required, draft and/or assist with the preparation of trial-related documents, tools and templates, including newsletters
- Assist with assembly and review of regulatory packages for trial-related submissions to Regulatory Authority and IRB/IECs, in accordance with ICH GCP, applicable regulations and Company SOPs
- Set-up, maintain and manage TMF in collaboration with the ACPM/CPM and TMF personnel; responsible for assisting with ongoing and final QC checks of TMF; and ensuring compliance with SOPs
- Support ACPMs/CPMs with administrative duties (e.g. creation of presentations, travel and expenses, calendar management, copy work)
- Occasional travel including overnight stays is required
Unsere Anforderungen
- Experience in working as a Clinical Trial Assistant, or similar in large international clinical trials
- Knowledge of GCP and ICH Guidelines, awareness of FDA and/or EU regulations
- Ability to work independently and manage own workload
- Knowledge of medical terminology preferred
- Good verbal and written English skills
- Excellent communication skills and attention to detail, and ability to work in an international team environment
- Strong organizational and time management skills and ability to work on multiple concurrent assignments
- Highly proficient in MS Office Suite particularly Excel, Word, PowerPoint
- Attention to detail
- Strong service orientation
Please refer to Job Ref. 4736 when sending your application to:
Chiltern International GmbH
Katharina Kostorz
Resourcing Manager
Norsk-Data-Strasse 1
61352 Bad Homburg
Germany
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