Local Operations Manager (Sponsor Dedicated, Oncology)
$93,100–$232,800 year
On-siteDurham, North Carolina, United States
Job Summary
Lead country-level operational planning and execution for complex oncology trials, serving as the primary Sponsor contact and local operational lead. Drive study compliance by managing recruitment strategies, budget forecasting, and vendor oversight while ensuring inspection readiness through rigorous data quality management and CAPA implementation. Coordinate site selection, investigator meetings, and informed consent documentation, proactively identifying risks and escalating issues to study management. Mentor local teams, support regulatory approvals, and deliver advanced trial management for high-priority studies requiring independent decision-making.
Required Qualifications
- BA/BS degree
- Degree in a health or science-related field
- 3 to 5+ years of trial management experience
- Experience independently managing complex clinical trials
- Experience leading country-level trial execution activities
- Oncology experience
- Strong working knowledge of ICH-GCP
- Strong working knowledge of Sponsor SOPs
- Strong working knowledge of local laws and regulations
- Strong working knowledge of assigned protocols
- Strong working knowledge of associated protocol-specific procedures
- Strong IT skills in appropriate software and Sponsor systems
- Willingness to travel with occasional overnight stay away from home according to business needs
- Proficiency in speaking the country language
- Proficiency in writing the country language
- Proficiency in speaking English
- Proficiency in writing English
- Good written communication skills
- Good oral communication skills
- Ability to truthfully and completely submit all information and credentials in the application
- Ability to comply with applicable law regarding candidate fraud policies
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