Associate Data Manager – Clinical Data Sciences

CRI1

2 months ago

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

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

Experience in management of medical and clinical study records and documentation