Senior Trial Operations Specialist
hace 1 semana
We are seeking an accomplished Sr. Trial Operations Specialist to oversee local trial management services in a country or countries. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials from start-up to closeout.
About the Role:- Oversight of assigned projects at the country level for end-to-end project management.
- Ensure adherence to Sponsor SOPs, WIs, policies, GCP, local regulatory requirements.
This position involves serving as the primary company contact for assigned trials at the country level and monitoring local/country teams' progress against planned timelines and patient recruitment rates.
Responsibilities:
- Develop local trial procedures and tools, recruitment planning, contingency management, and budget forecasting.
- Maintain and update trial management systems, utilizing study tools and management reports to analyze trial progress.
- Prepare for and conduct HA inspections and internal Quality Assurance audits.
- Communicate study progress and issues to study management teams and business partners.
- Bachelor's degree in a health or science-related field.
- Minimum of 5 years of local trial management experience in the pharmaceutical industry or CRO with CR experience.
- Working knowledge of ICH-GCP, company SOPs, local laws and regulations, assigned protocols, and protocol-specific procedures.
- Strong IT skills in software and company systems.
- Excellent communication and decision-making skills.
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