- Contribute to completion of project milestones and organize own work to meet project task deadlines.
- Participate in Data Monitoring and Management (DMM) activities including data review and query management.
- Ensure quality database design including documentation, testing, validation, and implementation of clinical data collection tools, and/or other data collection systems.
- Serve as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues.
- Ensure work is carried out in accordance with applicable Standard Operating Procedures (SOPs) and working practices.
- Investigate logic check flags, utilizing system information, as well as applicable study documentation.
- Liaise with Study Team Point of Contact, Document Owners, Trial master file (TMF) Study Owners and/or other end users to resolve document related discrepancies and issues.
- Identify and investigate any potential discrepancies and review findings with the study team Point of Contact to verify.
- Contribute to process improvement and additional project that may arise.
Qualifications
Must-Have
- Bachelor’s Degree
- Demonstrated experience or knowledge of ICH/GCP (International Council for Harmonization/ Good Clinical Practice) documentation requirements
- Hands-on experience with electronic documentation management systems and/or web based data management systems
- Awareness of clinical development process including knowledge and understanding of the principles of Good Clinical Practice
- Understanding of regulatory requirements and relevant data standards
- Consistent, detail-oriented, and dedicated to excellence
- Strong oral and written English communications skills
- Proficiency in the use of Microsoft Office Suite of tools
Nice-to-Have
- Experience in management of medical and clinical study records and documentation
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