Your responsibilities
- Support Clinical Trail Leader and Clinical Trial Manager in all trial related activities during preparation, conduct and report phase of trial, including but not limited to trial team correspondence, clinical trial documents, vendor contracting, drug supplies, logistics, budget planning.
- Supervision of smooth trial conduct via oversight systems
- Collaboration and interaction with involved trial level functions (e. g. Trial Statistician (STAT), Trial Data Manager (TDM)) and interface functions (e. g. global ClinOps, Clinical Trial Supplies Unit, Purchasing, Legal).
- Smooth cooperation with external functions (e. g. Clinical Research Organizations, advisors, investigators) to conduct clinical trials.
- Support development of approriate trial related training modules for trial team and investigators. And maintain flow of information as needed. Organization of training sessions, if needed.
- Organization and supervision of all trial related wrap-up activities (e. g. compliation of clinical trial report)
- Preparation, finalization and archiving of documents/records related to clinical trials, in accordance with internal and external regulations and guidances, and in adherence to the clinical trial document management process.
- Compilation of international documents on trial level, needed to conduct a clinical trial (e. g. investigator site file (ISF) documents, vendor documents) in close collaboration with CT Leader, Site Monitoring Lead (SML) and other involved functions.
- Compilation of national documents on local level, needed to conduct a clinical trial (e. g. investigator site file (ISF) documents, vendor documents) in close collaboration with CT Manager, Clinical Research Associate (CRA) and other involved functions.
- Supervision of document archiving in Trial Master File (TMF) and assurance of accuracy of TMF, in close cooperation with TRS/LTRS. Archiving of other trial relevant records in IDEA for GEN or any other BI system, per requirements.
- MF Records Specialist (TRS)/Local TMF Records Specialist (LTRS)
- Perform Quality Checks regarding legibility, content and internal requirements on all essential electronic and / or paper records to be filed in the TMF before importing an electronic document or, if applicable, completing the submission sheet for paper documents within the given time frame.
- Report on completeness at the stated time points according to the applicable regulations, SOPs, Manuals, Business Practices etc. in order to verify completeness and proper quality of the TMF by comparing available documents against the expected documents as well as by verifying correct and proper naming and filing location as specified in the List of Essential Records (LoER). Maintain an accurate and up to date list of expected documents for each level of responsibility (Trial, OPU, each site).
- Close collaboration with the trial team in order to provide feedback on the status, quality and completeness of the TMF during the entire lifecycle of the trial and to provide support for inspections and audits.
- Responsible for the essential document management process with investigational sites in Clinergize during the complete lifecycle of a trial
Your profile
- Master's degree in natural sciences or similar disciplines or completed vocational training with experience in clinical trials and development projects
- Relevant experience in Pharmaceutical industry
- Strong and track proven background in administrative management of clinical trials.
- Highly developed communication and interpersonal skills.
- Client oriented thinking in communication with internal and external stakeholders.
- Basic understanding of the relevant aspects of the clinical development process.
- Fluent (oral and written) English and German language skills
- Proficiency in all common office software and smooth self training of new software programmes (user).
Your benefits
- Working in an international company
About Hays
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.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
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