Parexel is on the lookout for an Associate Clinical Operations Leader (Senior Clinical Trial Specialist) to join our dedicated team in the UK, focusing on a single sponsor. In this pivotal role, you will collaborate closely with the Clinical Trial Manager (CTM) and the broader clinical trial team to ensure that all activities align with Good Clinical Practice (GCP) and our established Standard Operating Procedures (SOPs). Your keen eye for detail will help in identifying potential issues promptly and escalating them to management when necessary.

You may also be involved in overseeing service providers, managing service delivery quality, and ensuring that the financial health of assigned clinical studies is maintained while tracking important study milestones.

As an Associate Clinical Operations Leader at Parexel FSP, you will enjoy long-term job security and ample growth opportunities within a dynamic environment. We conduct essential clinical studies for industry-leading biotechs and top global pharmaceutical companies, supported by a robust pipeline of work.

Expect to engage in fascinating professional challenges within inspiring studies while maintaining a healthy work-life balance.

Some travel will be required, estimated at 15% to 20%.

Key Responsibilities

• Assist with activities related to study/site feasibility, initiation, maintenance, and closure.
• Manage the review, collection, and tracking of essential study and site documents.
• Support the creation and ongoing management of core study documents, including Informed Consent Forms, study plans, and training materials.
• Oversee the Trial Master File (TMF) to ensure all required documents are received, reviewed, and filed in compliance with GCP and relevant regulations.
• Organize study-related meetings, including agenda preparation, note-taking, and maintaining risk/issue/decision logs. Lead and present at meetings as required.
• Participate in departmental, study team, and service provider meetings.
• Engage in collaborative efforts for study-related activities, such as protocol development and service provider selection.
• Complete and review monitoring visit reports and conduct co-monitoring or oversight visits.
• Track and manage site and service provider queries and facilitate rapid responses to internal and site QA audit findings.
• Coordinate activities with third-party service providers, including managing timelines, deliverables, and metrics.
• Maintain general study tracking, including status updates, enrollment figures, and deviations.
• Support clinical site performance oversight and monitoring visit coordination.
• Assist with study data activities, including data review, query resolution, and safety reviews.
• Verify service provider activities for compliance and quality.
• Contribute to study reporting and tracking using applicable systems and technologies.
• Aid study leads in aligning timelines across functions and managing financials concerning service providers.

Qualifications

• A Bachelor’s degree in a related field, nursing degree, or equivalent education is required; a science background is preferred.
• At least 5 years of relevant industry experience in clinical studies (Pharmaceutical, Biotech, or CRO), with a focus on site monitoring preferred.
• Strong understanding of GCP regulations and SOPs is essential.
• Familiarity with study phases and their relevance to clinical development is beneficial.
• Proven ability to work both independently and collaboratively within a team.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Knowledge of electronic systems such as Trial Master Files (TMF), Clinical Trial Management Systems (CTMS), etc. (e.g., Veeva Vault, Smartsheet, SharePoint).
• Understanding of database management applications is a plus.
• Excellent verbal and written communication skills are required.
• Willingness to travel 15% to 20% may be necessary.

At Parexel, we value our people and their enthusiasm, as they are vital to our success. We forge an open and friendly workplace that empowers individuals and offers numerous opportunities for career development. You will have the chance to grow within your role and take on additional responsibilities or expand your skills in other relevant areas.

About Parexel

At Parexel, we are committed to supporting clinical studies across diverse therapeutic areas, backed by long-standing partnerships with a wide range of clients. We have played a vital role in the development of many of today’s top 50 best-selling drugs, while also facilitating niche drug developments crucial for patient well-being. You’ll be an influential member of our expansive team.

Not Quite the Right Fit?

If this role doesn’t align with your current career goals, we encourage you to join our Talent Community. By signing up, you will receive job alerts tailored to your interests and stay updated on the latest company news and events.

Join us today!