Clinical Trial Manager at ICON plc
A unique opportunity has arisen at ICON for a Centralised Clinical Trial Manager in Bangalore or Chennai. This pivotal role is integral to maintaining the integrity and quality of clinical trial reports, which are crucial for the advancement of medical research. The position demands effective communication among teams to ensure seamless operations. Interested candidates with a strong background in clinical research and a passion for a non-clinical career are encouraged to apply.
About ICON:
ICON is a global healthcare intelligence and clinical research organisation dedicated to accelerating the development of new medicines and treatments. With a mission to enhance patient outcomes, ICON operates with core values of integrity, collaboration, agility, and inclusion, fostering a work environment that prioritises these principles in interactions with employees, clients, and patients.
Job Details:
- Company: ICON
- Location: Bangalore, Chennai, Bengaluru
- Reference Number: JR145001
- Department: ICON Full Service & Corporate Support
- Field: Clinical Trial Management
- Work Arrangement: Remote or Office
Job Description:
The Centralized Clinical Trial Manager will be responsible for reviewing site visit reports according to protocols and ensuring high-quality standards. This role involves acting as a liaison between Clinical Research Associates (CRA), Clinical Trial Managers (CTM), and Project Managers (PM) to resolve issues promptly and efficiently.
Key Responsibilities
- Effectively review visit reports as per Protocol and ICON and Sponsor SOPs, ensuring high-quality standards and minimizing errors.
- Follow up on action items and protocol deviations, liaising between CRA, CTM, and PM for timely issue resolution.
- Act as an extension of the CTM team for visit report review and approval.
- Observe and escalate safety trends in patients identified in visit reports.
- Recognize and adhere to ICON’s values focused on People, Clients, and Performance.
- Create a culture of process improvement with a focus on streamlining processes to meet client needs.
- Ensure turnaround time of visit reports per contract and ICON/Sponsor SOPs.
- Attend project meetings and provide suggestions for quality improvement of reports.
- Liaise with CTM to communicate trends, outstanding issues, and safety concerns.
- Ensure necessary trainings are completed to improve job performance.
- Maintain thorough knowledge of ICH GCP and relevant regulations for clinical trials.
- Be computer literate and willing to travel if required.
Eligibility Criteria for this Clinical Trial Manager:
- Bachelor’s degree in life sciences, healthcare, or a related field (advanced degree preferred).
- Minimum 8-10 years of Clinical Research experience with at least 5 years of on-site monitoring experience.
- Experience in On-Site Monitoring and Clinical Trial Management.
- Strong analytical skills with proficiency in clinical trial data review and interpretation.
- Excellent organisational and project management skills.
- Effective communication and interpersonal skills.
Skills Required for this Clinical Trial Manager:
- Proficiency in clinical trial management software
- Strong problem-solving abilities
- Attention to detail
- Ability to work under pressure
- Adaptability to changing environments
