Senior Clinical Trial Coordinator/Project Specialist - UK (Home-based) - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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, as applicable, 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. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

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 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.

Requirements

• 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 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.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. You’ll be an influential member of the wider team.

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