Employer Sponsored Job (Free to apply to)
Clinical Trial Associate FSP Clinical
PAREXEL International Corporation
Own the challenges that lead to innovation and growth
Promoted to Head of Biotech Operations for Americas East, helping clients develop novel therapies with a focus on patient needs.
Advanced to Corporate VP Clinical Operations to lead Site Monitoring for Americas, Europe and SE Asia.
Streamlined Parexel’s clinical operations model; driving effectiveness, and increasing employee, client and site satisfaction.
Promoted to VP Clinical Operations, and relocated to the US in 2017.
Promoted to Senior Director of Clinical Operations for the Americas, consolidating both North and South American regions.
Joined Parexel as Director of Global Monitoring Operations for Latin America.
Create the solutions that drive global projects to success
Promoted to Senior Director, Project Management. Taking on management responsibilities for dedicated Enterprise accounts and enhancing his contributions to Parexel’s Global Project Leadership.
Managing Project Director role for dual Enterprise accounts, with a focus on client delivery and satisfaction in order to bring in new awards and expand growth.
Assumed the role of Global Project Leadership Training Coordinator, ensuring new PLs are properly inducted in all regions, while leading cross regional meetings to review and update training materials for PLs.
Promoted to Associate Director in Project Management at Parexel working on post-approval smoking cessation treatment.
Joined Parexel as a Senior Project Lead mentoring and managing 5 project managers working on a phase IV smoking cessation treatment.
Be part of a diverse team that drives healthcare innovation
Advanced into Senior Manager, Human Resources
Promoted to Manager, Human Resources Operations
Joined Parexel as a Human Resources Operations Partner.
Human Resources Business Partner at leading pharmaceutical company.
Manager of Diversity Resources.
Contribute to meaningful advances that benefit patients in need
Joined the Scientific Data Organization as Scientific Data Technology Director, creating agile access to real world data, bringing best in class technology solutions to Parexel services, and harnessing data to transform therapy development for patients.
Promoted to Director IT Project and Programme Office, leading engineering projects for Wearable and Sensor devices with a view to streamlining Clinical Trials patient engagement and approaches.
Promoted to Associate Director of IT Program and Project Management at Parexel.
Joined Parexel as a Project Manager in the IT Project Program Office.
Own the challenges that make you grow
Promoted to Senior Medical Writer, focusing on the development and support of clinical documents intended for regulatory submission.
Began a new role working remotely as a Medical Writer II, researching and coordinating the development of clinical documents intended for submission to the FDA or other regulatory authorities.
Director of Imaging Operations leading a team of 13 Project Managers and the imaging of over 130 clinical trials.
Senior Project Manager, overseeing standardization of program operations and deliverables while leading a team of Project and Imaging Research Managers.
Promoted to Project Manager for clinical oncology trials.
Joined Parexel as an Imaging Research Associate on clinical trials utilizing medical imaging.
Forge the relationships that elevate customer experience
Corporate Vice President, General Manager – Japan
Vice President, Growth Accounts
Senior Director of Business Development at Parexel.
Associate in the Proposal Development department at Parexel.
One of the founders and Marketing Director of an IT venture company developing web related systems
Voice the ideas that get treatments to patients faster
Promoted to Senior Director of Clinical Application Development and Technology.
Promoted to Associate Director of IT.
Promoted to Senior Programmer.
Joined Parexel in Clinical IT.
Received Master's in Computer Applications.
Own the challenges, program your future
Promoted to Senior Manager, Statistical Programming, with increasing responsibilities for department development and team supervision.
Advanced to Statistical Programming Manager, responsible for a dynamic, multinational team of over 12 people.
Increased responsibility, leading projects and managing small teams as a Principal Statistical Programmer / Associate Manager.
Promoted to Senior Statistical Programmer, participating in high profile trials for diverse range of sponsors, as main programmer.
Referred by a friend to join Parexel as a Statistical Programmer, taking the opportunity to further develop my programming skills in 4GL language using SAS® .
Natalia – Head of Biotech Operations for Americas East
Ruben – Senior Director
Deborah – Senior Manager
Scientific Data Technology Director
Nicholas – Senior Medical Writer
Shigehiro – Corporate Vice President, General Manager – Japan
Naresh – Senior Director of Clinical Application Development
Pawel – Senior Manager
Jobs at Parexel
Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. 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. We're not just the people with expertise, we're the people with heart.
Clinical Trial Associate FSP Clinical
USA - Any Region - Home Based
• Establish and maintain the Trial Master File (system or file room) in inspection-ready state
o Communicate directly with sites to drive collection of essential documents from start-up through study closure
o Ensure accurate and timely review and filing of clinical trial related materials
o Perform and support QC reviews of study, country and site files, including issue resolution
o Produce reports and status metrics as requested
• Establish and maintain the Clinical Trial Management System in inspection-ready state
o Maintain accurate and up-to-date site, vendor and internal study team contact information
o Track study progress and produce reports and status metrics as requested
o Assist with Investigational Product reconciliation
• Assist study team by performing administrative tasks as needed
o Schedule and run meetings, both in-house and remote by means of virtual conferencing system
o Prepare meeting agendas, minutes, and track action items
o Operate and navigate within clinical trial systems including but not limited to TMF, CTMS, ECMS, EDC
• May assist with the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, study binders, plans, presentations, and reports
o Ensure timely distribution of clinical trial related materials to sites, study team, field CRAs and vendors
• Under supervision of the Protocol Lead, may assist with the following:
o Perform limited data cleaning activities
o Review Informed Consent documents
o Perform Site/Site Management Organization Regulatory Monitoring
• Assist in preparation and follow-up of company-sponsored site quality audits as well as regulatory authority inspections
1 year of industry experience.
Strong TMF experience.
Oncology experience preferred.
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Last verified - 0 day(s) 8 hour(s) ago [What does Last Verified mean?]