Clinical Trial Coordinator - UK (Remote) - FSP
- Responsible for the planning, coordination and conduct of the review and operating unit level activities according to ICH-GCP and local law within the planning, conduct and reporting of clinical trials.
- Maintain tracking within systems to ensure oversight for the trial management regarding trial
- specific information and activities.
- Administration support, set up of local and/or global meetings and participation if applicable.
- Administrative support for the oversight of documentation via maintenance of trackers (ensures relevant documents are prepared in time incl. translations as applicable).
- Support authoring of local required documents in EDMS as applicable.
- Coordinate interaction between Document Contributor and final processing.
- Ensure effective and efficient interface management through professional communication and interaction with local trial team, sites and local vendors as applicable.
- Management and coordination of local supply (e.g. trial drug, pregnancy test, ...) needed at sites as applicable.
- Ensure the appropriate set-up and maintenance of trial related systems and tools under own responsibility in close cooperation with the local trial team.
- Responsible for accuracy of data, user account management, and functionality of systems.
- Coordinate work on queries in the systems.
- Validate information in respect to completeness and consistency among systems.
- University degree is essential. Preferably with a major focus in Business Administration or equivalent.
- Highly developed administrative skills, excellent document management and organisational skills.
- Highly developed communication and interpersonal skills.
- Capable of managing multiple assignments and able to work independently.
- Good understanding of project related priorities; an agile and solution-oriented mindset.
- Strong verbal and written communication skills (cultural-sensitive, clear and transparent).
- Strong MS-Office skills (Excel, Word, Power Point, Outlook etc.).
- Good understanding of regulatory framework (e.g. local requirements, ICH-GCP, appropriate SOPs, BPs etc.
- Basic understanding of the relevant aspects of the clinical development process.
- Fluent (oral and written) English language skills.
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