About the role
AI summarisedThe Clinical Trial Manager is responsible for achieving final clinical deliverables within contract timelines, ensuring all clinical activities meet customer expectations regarding time, quality, and cost. This role involves managing low to moderate complexity studies within a team setting.
Life SciencesOnsite
Key Responsibilities
- Manage all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
- Develop clinical tools such as Monitoring Plans and Monitoring Guidelines alongside the Data Quality Plan.
- Collaborate on the design of CRFs, CRF guidelines, and patient informed consent templates as required.
- Lead team meetings, maintain timelines, resources, and quality standards for the clinical team.
- Ensure achievement of final clinical deliverables by monitoring activity timelines, providing status updates, and managing query resolution.
- Monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
- Communicate with study sites regarding protocol, patient participation, and case report form completion issues.
Requirements
- Strong attention to detail.
- Solid understanding of relevant regulations (e.g., ICH/GCP, FDA guidelines).
- Proficiency in computer applications including Outlook, Excel, and Word.
- Ability to manage clinical operations for low to moderate complexity studies.