Associate Clinical Operations Leader - UK (Remote) - FSP

Parexel is seeking an Associate Clinical Operations Leader (Senior Clinical Trial Specialist) to join us in the UK, dedicated to a single sponsor. This role supports the Clinical Trial Manager (CTM) and the wider clinical trial team to ensure activities are conducted according to Good Clinical Practice (GCP) and relevant SOPs, helping to identify issues in a timely manner and escalate to management as appropriate. It may involve assisting with service provider oversight and management, identifying issues in a timely manner and escalating to management as appropriate. The Associate Clinical Operations Leader will support the CTM in ensuring the financial health of assigned clinical studies as well as oversight of study milestones.

Note: Some travel will be required - 15% to 20%.

• Support activities related to study/site feasibility, start-up, maintenance, and close-out.

• Manage study and site essential document review, collection, tracking, etc.

• Support the initiation, preparation and maintenance of core study documents (Informed Consent Forms, study plans, site and patient materials, training and guidance documents, pharmacy, clinical supply and laboratory related documents, etc.).

• TMF oversight - ensure required study documents are received, reviewed and filed in the TMF in accordance with GCP and applicable regulations.

• Organise study-related meetings including preparation of agenda, minute taking, and maintenance of risk/issue/decision logs. Lead and present at study-related meetings as necessary.

• Support and participate in departmental, study team, and service provider related meetings.

• Participate in study-related collaborative efforts and reviews (protocol development, service provider selection, departmental initiatives, etc.).

• Complete monitoring visit report review and perform co-monitoring or monitoring oversight visits.

• Support, track and triage site and service provider queries.

• Support rapid actions to address internal and site QA findings from audits.

• Manage, coordinate and oversee activities from third-party service providers including timelines, contract deliverables, metrics, accruals, and process planning.

• General study tracking and maintenance, including study status, enrolment, deviations, and study-level documents and plans.

• Support oversight of clinical site performance, metrics, monitoring visits, etc.

• Assist and support study data-related activities including data review, query creation and resolution, protocol deviation reviews, safety reviews, etc.

• Review and verification of service provider activities.

• Support study reporting and tracking with applicable systems and technology.

• Support study leads in cross-functional alignment of study timeline and in financial management of service providers (contract and invoice reconciliation).

• Bachelor's, nursing degree or equivalent required; science preferred.

• 5+ years of industry experience in clinical studies (Pharmaceutical, Biotech or CRO), including at least a role with site monitoring experience preferred.

• Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.

• Understanding of study phases and how they apply to clinical development.

• Ability to work independently and in a team environment.

• Advanced knowledge of Word, Excel, and PowerPoint.

• Working knowledge of electronic systems including Trial Master File, CTMS (e.g., Veeva Vault, Smartsheet, SharePoint).

• Knowledge of database management and computer applications.

• Strong verbal and written communication skills.

• Travel: 15% - 20% may be required.