Clinical Trial Manager
GRAIL
Google Cloud Platform
Associate Clinical Operations Leader – FSP
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud PlatformVault
About the role
- 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 - ensures required study documents 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 (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 study status, enrolment, deviations, study level documents and plans.
- Support oversight of clinical site performance, metrics, monitoring visits.
- Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews.
- 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).
Requirements
- Bachelor’s, nursing degree or equivalent required, science preferred.
- 5 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 (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.
- Willingness to travel 15% - 20% as required.
Benefits
- Tremendous long-term job security and prospects.
- Time for your outside life (work-life balance).
- Opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments.
- Open and friendly work environment that empowers people and provides opportunities to develop long-term careers.
- Opportunity to join Parexel Talent Community for job alerts and company updates.
- Some travel required (15% - 20%).
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study managementsite monitoringstudy document managementdata reviewquery creationprotocol developmentrisk managementaccrual managementfinancial managementstudy reporting
Soft skills
independent workteam collaborationcommunicationorganizational skillspresentation skillsproblem-solvingattention to detailleadershiptime managementmeeting facilitation
Certifications
Bachelor's degreenursing degreeGood Clinical Practices (GCP) knowledge
