Latest Job for Life Science Graduate!
ICON plc is actively seeking qualified life science professionals to join our team as Clinical Trial Managers. As a global leader in clinical research, ICON offers a dynamic and innovative work environment where you can contribute to advancing healthcare through groundbreaking clinical trials. If you’re passionate about improving patient outcomes and have a strong background in life sciences, we invite you to explore this exciting career opportunity with us. Join ICON and be a part of shaping the future of clinical trials.
Job Post: Clinical Trial Manager
Company: ICON plc
Location: Reading, England, United Kingdom
Employment Type: Full-Time
Qualification: Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification.
Required Skills and Experience: Latest Job for Life Science Graduate
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields
- Good knowledge of international guidelines ICH- GCP as well as relevant local regulations.
- Excellent verbal and written communication skills.
- Excellent knowledge of spoken and written English
- Ability to travel nationally and internationally as required.
Roles and Responsibilities: Latest Job for Life Science Graduate
- Has the overall responsibility for the study commitments within the country and for the timely delivery of data to the required quality.
- Leads Local Study Team consisting of CRA(s), CTA(s), for assigned study/studies
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely submission of applications/documents to EC/IRB at start-up and for the duration of the study.
- Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with SOPs.
- Sets up and maintains the study in CTMS at the study country level as well as local websites as required by local laws and regulations.
- Oversees manages, and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviews monitoring visit reports (as required and following SOPs) and proactively advises the monitor(s) on study-related matters.
- Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
- Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP.
Benefits:
- Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
- Home-based
- Permanent contract
- Great work atmosphere
- Compensatory time-off
