Job Overview:
Joining Covance Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team-oriented workplace, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class leading global healthcare company. Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support of both a dedicated Covance line manager and our client project teams.
Your role as Clinical Data Coordinator
- 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 submit the review of clinical trial data.
- Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification I 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 I or third party vendor data (eCRF, edDiary, specialty laboratory, etc.).
- Perform aggregate review of clinical data by patient, site and I or project to identify data trends (patient safety, compliance, etc.) and I or data inconsistencies that require further investigation.
- Apply quality control proced ures 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), monitori ng conventions, CRF (eCRF) completion guideli nes, 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 gu idel ines I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF(eCFR) completion I monitori ng conventions.
- Assist in the development and testing of data management system edit I data validation checks (diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
- Potentially interact and collaborate with other project and specialty team members (clinical, programmi ng, statistics, CDM technical support, drug safety, etc.) to supp01t 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 traini ng of project staff on project-specific, global, standardized data management processes.
- Perform other duties as assigned by management.
Education/Qualifications:
+ 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 ofICH Guidelines and GCP includ i ng international regulatory requirements for the conduct of clinical development programs.
+ Fluent i n English, both written and verbal.
Experience:
- Previousrelevant workexperience with increasingresponsibility in data management with knowledge of one (I) or more therapeutic
- Demonstrated time management skill and ability to adhere to project productivity metrics and ti
- Potential ability to lead by example data management s
- Demonstrated ability to work i n a team enviro1m1ent and collaborate with
- Demonstrated interpersonal skill
- Excellent oral and written communication
- Ability to demonstratea constructive problemsolving attitude while dealingwithtime demands, incomplete information or unexpected events.
