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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.
Associate Clinical Operations Leader (CTS) - FSP
Job ID R0000035665Job Summary:
The Associate Clinical Operations Leader (CTS) is responsible for study management of assigned projects to drive on-time delivery of clinical trial milestones.
KeyAccountabilities:
Oversight of Project Cycle
- Leading and supporting clinical trials end to end, start up through closeout activities
- Performs study oversight to ensure regulatory and study requirements are being fulfilled
- Maintains thorough understanding of current monitoring practices
- Creates and provides input into study management requirements and tools, monitoring tools and manuals and training tools
- Reviews study records including case report forms, consent forms, and other materials
- Provides input, tracks progress, and works to implement corrective action plans for study and individual site recruitment and retention plans
- Provides quality and timely study documentation, including trip reports, tracking, and site/sponsor communications in accordance with standard operating procedures
- Maintains accurate and timely sponsor/site communication and correspondence
- Responsible for ensuring Investigational Medicinal Product (IMP) and supplies accountability
Collaborative Relationships
- Develops and maintains collaborative relationships with investigational sites, study teams, Contract Research Organization (CRO) teams, and vendor teams
- Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols
Compliance of Parexel Standards
- Complies with required training curriculum
- Completes timesheets accurately and timely 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:
- Knowledge and expertise to review and evaluate medical data
- Well-versed in remote monitoring approaches
- Excellent written and verbal communication, problem-solving, and interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Ability to travel (minimal travel required)
- Proficient in Microsoft Office Suite (Excel, Word, and PowerPoint), familiar with Microsoft Project
- Proficiency in written and spoken English required
- Proficiency in local language as applicable
Knowledge and Experience:
- 3 years oversight of clinical trials in SSU through closeout in a CRO/pharma capacity, including site management or equivalent
Education:
- Bachelor of Science (BS)/Bachelor of Arts (BA) degree required, degree in healthcare scientific field preferred
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