Labcorp Drug Development has an exciting opportunity for a Senior Clinical Data Manager. The Senior Clinical Data Manager will be remotely (home-based) located anywhere within the United States or Canada.
- 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 setup and application,
- Perform reconciliation of the clinical and safety databases.
- Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, 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 Labcorp Drug Development) are achieved.
- 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 (eCRF) 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.
- 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.
- Serve as client contact for project meetings and CDM status updates.
- Potentially support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
- Support the training of project staff on project-specific, global, standardized data management processes.
- Maintain technical data management competencies via participation in internal and external training seminars.
- Review literature and research technologies/procedures for improving global data management practices.
- 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).
- Additional relevant work experience will be considered in lieu of formal qualifications.
- Broad knowledge of drug development processes.
- Understanding of global clinical development budgets and relationship to productivity targets.
- Knowledge of effective clinical data management practices.
- Knowledge of time and cost estimate development and pricing strategies.
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
- Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
- Demonstrated skill for technical management of staff exceeding 5 employees.
- Financial management of gross revenues in excess of $250K per year.
- Excellent oral and written communication and presentation skills.
- In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
- Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
- Demonstrated managerial and interpersonal skills.