Clin Data Coord II

Job Overview:

Clinical Data Coordinator II

At Covance, we value your unique point of view and bold ideas to advance modern healthcare. Join our team and see how our collaborative work environment along with mentoring, training and career development can help you be successful at work and in your personal life.

Together, let’s shape new possibilities for your career and advance healthcare around the world.

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 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.

Why choose to work at Covance Make a direct impact in the lives of patients Become successful in the position with exceptional training Join a high-energy and team-driven workplace Open up new opportunities for career growth

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us. Education/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 the two (2) 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. Experience:Minimum two (2) years relevant work experience with increasing responsibility in data management with knowledge of one (1) 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.