Covance
Solutions Made Real
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
Job Title: Clinical Data Lead I, Assistant Manager
Job Number : 2018-17768
Job Description:
- Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications and project timelines and productivity targets.
- 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.
- Serve as the technical data management leader on small to moderate project 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.
Essential Job Duties:
- 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 ancilliary programs (e.g. Diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
- Generate, resolve and trach queries to address problematic data identified during data review activities and apply proper modification / correction to the data base.
- 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, eDiary, specialty laboratory, etc)
- Apply quality control procedures and checks to ensure data quality standards(client and Covance) 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 clinical data model and / or database design and annotate the CRF (eCRF) accroding 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(clincal, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintainence, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Serve as a contact for project meetings and CDM status updates.
- Potentially support for 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.
Qualifications:
Minimum Required
- 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 4 years relevant work experience in data management will be considered.
- Broad knowledge of drug development process.
- understanding of global clinical development budgets and relationship to productivity targets.
- Knowledge of effective clinical data management practices.
- Cursory 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.
Experience
Minimum Required
- Minumum 4 years of relevant 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.
- Excellent oral and written commnication skills.
- 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.
- Potential ability to lead by example data management staff.
- Demonstrated ability to work in a team environment and collaborate with peers.
- Demonstrated interpersonal skills.
