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Parexel is currently seeking an Associate Clinical Operations Leader (Senior Clinical Trial Specialist) 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 SOP's and 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
Working as an Associate Clinical Operations Leader 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.
Please note that some travel will be required - 15% - 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.
- Supports 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 - ensures required study documents received, reviewed and filed in the TMF in accordance with GCP and applicable regulations.
- Organise study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs. (Leading and presenting 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 both internal and site QA findings from audits.
- Manage, coordinate and oversee the activities from third party service providers including timelines, contract deliverables, metrics, accruals, process planning, implementation, etc.
- General study tracking and maintenance, including but not limited to study status, enrolment, deviations, study levels documents and plans, etc.
- Support oversight of clinical site performance, metrics, monitoring visits, etc.
- Assist and support study data related activities including data review, query creation and resolution, study and 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).
Here are a few requirements specific to this advertised role.
- Bachelor’s, nursing degree or equivalent required, science preferred.
- 5 or more years of industry experience in clinical studies (Pharmaceutical, Biotech or CRO), including at least a
- 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.
- 15% - 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.
Who Are 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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