Associate Clinical Operations Leader - UK (Remote) - FSP

Overview

Parexel is currently seeking an Associate Clinical Operations Leader (ACOL) to join us in the UK, dedicated to a single sponsor. This role will be responsible for supporting 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 escalating to management as appropriate. It may involve assisting with service provider/vendor oversight and management, and supporting the CTM in ensuring the financial health of assigned clinical studies as well as oversight of study milestones. Working as a Clinical Trial Specialist at Parexel FSP offers long-term job security and prospects with a pipeline of work across sponsors including leading global biotechs and Pharma Top 50. There are exciting professional challenges in inspiring studies, with time for your outside life. This role could be a good opportunity for CRAs looking to reduce travel or for ICRAs seeking progression. Some travel will be required (10%-20%).

Responsibilities

• 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.).

• Study Trial Master File (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 agendas, minute taking and maintenance of risk/issue/decision logs. Leading and presenting at study-related meetings as necessary.

• Lead and present at study-related meetings as necessary.

• Occasionally perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring, close-out visits) as required.

• Provide rapid action to address internal and site QA findings from audits.

• If required, manage, coordinate, and oversee the activities from third-party vendors including deliverables metrics, accruals, process planning, and implementation.

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

• Study site oversight including site performance, metrics, monitoring report review, etc.

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

• Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives).

• Work cross-functionally and provide oversight of CRO and vendor activities, including vendor management as assigned.

• Review and verification of contracted vendor activities including vendor invoice review.

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

• Support study leads in cross-functional alignment of study timelines.

Qualifications

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

• 3 or more years of industry experience in clinical studies (Pharmaceutical, Biotech or CRO).

• Previous site monitoring experience is preferred.

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

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

• Demonstrated 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, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).

• Knowledge of the principles and practices of computer applications in database management.

• Strong verbal and written communication skills required.

• 10%-20% travel may be required.

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.

About 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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