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 is meeting 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 is meeting 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
- Identifying risks, trends, and issues and proactively initiating corrective and preventive actions
- 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
- Contributing to patient understanding of protocol and patient safety
- Ensuring trial subject safety
- Ensuring Inspection Readiness
- 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
- 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
- Specific therapeutic area experience may be required depending on the position
- 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