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.
Clinical Trial Specialist - FSP
Job ID R0000031547Job Summary:
As a member of a global study team, the Clinical Trial Specialist (CTS) is responsible for study management and monitoring of assigned projects in accordance with SOPs, Good Clinical Practice, International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines, local regulations and additional sponsor requirements. The CTS will participate in company, departmental and project team meetings. This position reports into Clinical Operations.
Summary of Key Responsibilities:
- Demonstrates study and clinical investigative site management according to Good Clinical Practices, ICH Guidelines, local regulations, and SOPs.
- Creates and provides input into study management requirements and tools, monitoring tools and manuals and training tools.
- Maintains thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
- Performs study oversight and study site visits to ensure regulatory and study requirements are being fulfilled.
- Reviews study records including case report forms, consent forms, and other materials, and is versed in remote monitoring approaches.
- Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols;
- Provides input, tracks progress, and works to implement corrective action plans for study and individual site recruitment and retention plans.
- Develops and maintains collaborative relationships with investigational sites study teams, CRO teams, and vendor teams.
- Produces quality and timely study documentation, tracking and site/sponsor communications in accordance with standard operating procedures.
- Maintains accurate and timely Sponsor/site communication and correspondence.
- Responsible for ensuring IMP and supplies accountability.
- Participates in company, departmental and project team meetings.
Requirements
- BS/BA degree required; degree in healthcare scientific field preferred.
- 3 years CRO or Pharma industry experience including some study management/study lead experience (phase I preferred)
- 1 year CRO management or CRO oversight experience of clinical trials, including site management, in CRO or Pharma space.
- Knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data.
- 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 with MS Office Suite (Excel, Word and PowerPoint), familiar with MS Project.
#LI-REMOTE
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs