Senior Clinical Operations Specialist
2 weeks ago
We are seeking a seasoned Clinical Operations Specialist to join our clinical research team.
About the RoleThis is a mid-senior level position requiring strong leadership and technical skills in managing all aspects of clinical trials, including protocol preparation and EC approval.
The ideal candidate will have a bachelor's degree in biomedical or science discipline and 3-10 years of experience as a clinical operation monitor, with excellent communication and organizational skills.
- Manage all aspects of clinical trials from protocol development to site closure.
- Coordinate trial conduct, ensuring compliance with GCP and SOP guidelines.
- Contribute to query resolution and provide timely updates to EDC/CTMS systems.
- Report and follow up on SAEs/adverse drug reactions.
- Develop and implement clinical trial protocols in accordance with regulatory requirements.
- Oversee trial conduct, ensuring adherence to GCP and SOP standards.
- Collaborate with cross-functional teams to resolve queries and issues.
- Ensure accurate and timely documentation of trial data.
- Bachelor's degree in biomedical/science discipline or equivalent.
- At least 3-10 years of clinical operation monitor experience.
- Excellent communication and organizational skills.
A successful candidate will be able to demonstrate strong leadership skills, attention to detail, and ability to work independently in a fast-paced environment.
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