Key Accountabilities
-Perform data review and query management across clinical trial data, working with study team members and CRO partners to drive queries to resolution.
-Perform detailed review of eCOA and external data per the Data Review Plan – acting as liaison with eCOA and external data vendors, QCing a sample of vendor-processed data clarification requests, and maintaining the centralised study data issues log.
-Perform reconciliation of eCOA and external data against EDC data, and SAE reconciliation with the safety team, resolving discrepancies with the applicable parties.
-Contribute to the creation and maintenance of study data cleaning plan components – edit checks (data validation plan), listing review checks, data integration and transfer specifications, external data reconciliation plans, coding guidelines, SAE reconciliation guidelines and database lock plans – and perform additional review activities for interim and final database locks.
-Support set-up and testing of EDC, IRT, eCOA and ePRO tools; contribute to eCRF Completion Guidelines and associated documentation, and assist with account access and training materials.
-Maintain study documentation in the eTMF and department project files, perform periodic quality reviews, take meeting minutes, and complete data archival activities.
-Prepare and distribute performance metrics to stakeholders, escalate to the CDM Lead as needed, and support inspection readiness and internal and regulatory inspections.
-Coordinate, oversee and mentor other data coordinators, and assist with quality review of activities performed by the CRO.
Experience
-8 years of relevant experience preferred in data management or drug development within a GCP and clinical research regulatory environment, or an equivalent combination of training and experience.
-Working understanding of clinical trial documents – protocols, case report forms, data management plans, study reports – and the processes around them.
-Hands-on experience with electronic data collection systems, and a track record of managing multiple deliverables against competing deadlines.
-Knowledge of data management best practices and technologies, and of FDA and ICH regulations and industry standards applicable to data capture and data management.
Skills and Competencies
-Strong attention to detail, with good organisational and time management skills.
-Demonstrated communication and project management skills, effective across sponsor, CRO and vendor teams.
-Quick learner, comfortable adopting new technologies and systems; advanced knowledge of Microsoft Office.
-Comfortable with ambiguity, with strong teamwork, interpersonal, conflict resolution and problem-solving skills.
