- Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets.
- • Potential to assist in the development of the project Data Management Plan, including the creation of data acquisition conventions and data review guidelines / diagnostics specification; and set-up of the data management systems according to project requirements.
- • Potential to serve as the technical data management leader on small projects with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets.
- Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
- • Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
- • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.
- • Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.
- • Perform reconciliation of the clinical and safety databases.
- • Perform reconciliation of central laboratory and / or third party vendor data (eCRF, edDiary, specialty laboratory, etc.).
- • Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation.
- • Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved.
- • Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.
- • Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
- • Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
- • Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCFR) completion / monitoring conventions.
- • Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
- • Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- • Potentially serve as client contact for project meetings and CDM status updates.
- • Support the training of project staff on project-specific, global, standardized data management processes.
- • Perform other duties as assigned by management.
University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• In lieu of the above requirement, approximately 18 months experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one year’s clinical data management experience in addition to the 4 years relevant work experience in data management will be considered.
• Knowledge of drug development process.
• Knowledge of effective clinical data management practices.
• Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Fluent in English, both written and verbal.
Minimum 4 years relevant work experience with increasing responsibility in data management with knowledge of 2 or more therapeutic areas.
• Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
• Potential ability to lead by example data management staff.
• Demonstrated ability to work in a team environment and collaborate with peers.
• Demonstrated interpersonal skills.
• Excellent oral and written communication skills.
• Ability to demonstrate a constructive problem-solving attitude while dealing with time demands, incomplete information or unexpected events.