Global Clinical Trial Operations Specialist
hace 3 semanas
We are seeking an experienced Global Clinical Trial Operations Specialist to join our team at Ingepsy. This role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members.
About the Role:This position plays a pivotal role in the successful execution of clinical trials and contributes to process improvement initiatives. The successful candidate will work collaboratively with cross-functional teams to ensure high-quality deliverables and timely project completion.
Key Responsibilities:- Clinical Systems Management: Manage clinical systems, including CTMS milestone updates at Site / Country / Protocol levels.
- Data Review: Follow up with CRAs for resolution of outstanding issues / action items related to assigned tasks.
- Document Review: Review Initial / Amended Investigator Packages for regulatory compliance before granting green light for site patient enrollment.
4-5 years of work experience in clinical research, Strong working knowledge of ICH-GCP guidelines and other applicable regulations.
Demonstrated ability to plan, prioritize, organize, and communicate effectively. Attention to detail and high-quality work delivery. Strong interpersonal skills and ability to work collaboratively. Ability to influence and lead others. Ability to facilitate meetings.
Compensation:The estimated salary range for this position is $80,000 - $110,000 per year, depending on location and experience.
Ingepsy offers a comprehensive benefits package, including health insurance, retirement savings, and paid time off.
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