Parexel is currently seeking a Senior Clinical Trial Coordinator (Sr CTC) / Senior Project Specialist, to join us in the UK, dedicated to a single sponsor.
This role will be responsible for providing administrative support to enable clinical trial execution excellence and will work in close collaboration with the Regional Clinical Trial Managers (CTM), other trial team members and the investigational sites to ensure the quality and comprehensiveness of the site and country level Trial Master File (TMF) according to ICH-GCP, GDP, SOPs, WIs and local procedures.
Working as a Senior Clinical Trial Coordinator / Senior Project Specialist at Parexel FSP offers tremendous long‑term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50, and we have an incredible pipeline of work.
Responsibilities
* 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 for trial management oversight and relevant 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 including 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, etc.) 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.
Qualifications and Experience
* Education: Degree educated in any discipline.
* 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).
* Good understanding of regulatory framework (e.g., local requirements, ICH‑GCP, appropriate SOPs, BPs).
* Basic understanding of the relevant aspects of the clinical development process.
* Fluent (oral and written) English language skills.
#J-18808-Ljbffr