Description
We are seeking a Clinical Research Manager to serve as a subject matter expert and resource for quality and compliance standards across assigned studies.
The successful candidate will lead and contribute to quality Site Selection, ensure local/country team meets recruitment targets with high-quality data on time and within study budget, and act as primary Sponsor contact for assigned trial at the country level.
Key responsibilities include:
- Leading and contributing to quality Site Selection through participation in site feasibility and site qualification visits
- Ensuring local/country team meets recruitment targets with high-quality data on time and within study budget
- Acting as primary Sponsor contact for assigned trial at the country level
- Driving study compliance by maintaining and updating trial management systems and analyzing trial progress
- Leading development and execution of country-level recruitment strategies and contingency planning
- Delivering advanced vendor management at the country level
- Ensuring high standards for study monitoring and facilitating Site Manager training when needed
- Contributing to patient understanding of protocol and patient safety
- Ensuring trial subject safety and reporting adverse events within required timelines
- Ensuring Inspection Readiness by maintaining complete, accurate, and timely data and essential documents
- Providing oversight and guidance to improve site data quality and operational performance
- Keeping oneself inspection ready and knowledgeable for current work
- Working closely with Site Managers to ensure CAPAs are implemented for audits/inspections or any quality-related visits
- Ensuring accurate finance reporting and trial delivery within budget
- Keeping the trial in compliance with local regulatory requirements
- Serving as a trainer, mentor, and subject matter expert for systems/processes and local trial management practices
Requirements:
- BA/BS degree in a health or science-related field
- 3 to 5+ years of trial management experience, including experience independently managing complex clinical trials and leading country-level trial execution activities
- Oncology experience
- Strong working knowledge of ICH-GCP, Sponsor SOPs, local laws and regulations, assigned protocols, and 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
- Proficient in speaking and writing the country language and English