Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Clinical Trial Specialist- FSP
Job ID R0000034767Parexel FSP is seeking a Senior Clinical Trial Specialist. This is a remote position in the United States.
Key Accountabilities:
Oversight of activities
Supports activities related to all phase of clinical studies including; study/site feasibility, start-up, maintenance, and close-out.
Manages study and site essential documents 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.
Organization and preparation of study related meetings (agenda/ minutes /slides, etc.)
Preparation, oversight and maintenance of study logs (risk/ issue/ decision logs, etc.)
Supports and participates in departmental, study team, and service provider related meetings
Lead and present at study related meetings
Participates 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.
Supports, tracks and triages site and service provider queries
Supports rapid action to address both internal and site QA findings from audits
Manages, 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.
Supports 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.
Able to work cross-functionally
Review and verification of service provider activities
Supports study reporting and tracking with applicable systems and technology
Supports study lead in cross-functional alignment of study timelines
Supports study lead in financial management of Service Providers (contract and invoice reconciliation)
Collaborative relationships
Collaborate with cross-functional teams, service providers, and clinical sites to support all phases of clinical studies, from feasibility to close-out, ensuring efficient document management, meeting coordination, and oversight of study activities while contributing to protocol development and departmental initiatives.
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
Strong verbal and written communication skills
Demonstrated ability to work independently and in a team environment
Advanced knowledge of Word, Excel, and PowerPoint.
Ability to prioritize and manage multiple tasks simultaneously.
Knowledge and Experience:
5 or more years’ industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site management experience
Previous site monitoring experience is preferred
Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
Understanding of study phases and general knowledge of how they apply to clinical development
Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet’s, SharePoint, etc.)
Knowledge of the principles and practices of computer applications in database management
15-20% travel may be required
Education:
Bachelor’s degree preferred
Clinical experience is preferred
#LI-SS1
#LI-REMOTE
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs