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 Manager - FSP
Job ID R0000039509 , United KingdomKey Accountabilities:
- Manage external vendors and contract research organizations
- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
- Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
- Assist with protocol development and study report completion
- Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
- Provide guidance, direction, and management to CRAs
- Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
- Coordinate study supplies
- Negotiate contracts with vendors of clinical trial services
- Review Informed Consent Forms, CRFs, and study related materials
- Plan and participate in investigator meetings
- Assist and support data query process
- Ensures trial master file is current and maintained
- Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials.
Skills:
- Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.
- Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.
- Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment
- Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders
Knowledge and Experience:
- Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)
- Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)
- Experience of data management and query resolution in clinical trials
- Overall knowledge of site management and monitoring procedures
Education:
- Degree in the life sciences field preferred
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