Sr Clinical Data Specialist at Fortrea, Apply Now!
Are you an experienced Clinical Data Management (CDM) professional looking to advance your career? Fortrea is hiring a Senior Clinical Data Specialist to join their dynamic team. This role offers the opportunity to ensure high-quality clinical data delivery while collaborating with project teams and adhering to timelines and budget targets. If you have 4–6 years of CDM experience and a passion for data integrity and quality, this position is the perfect next step.
Job Overview
Serve as a member of the project team with primary responsibility for clinical data review, query generation/resolution, and reconciliation. Potential to assist in the development of project Data Management Plan and serve as the operational data management leader.
Summary of Responsibilities for Sr Clinical Data Specialist:
- 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.
- 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 Fortrea) are achieved.
- Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRF Completion guidelines, Data Management Plans, Perform Data review utilizing all applicable documents such as protocols, CRFs (or eCRFs and eDiary) 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 preferred for Sr Clinical Data Specialist.
- Assist in the review of the database design and annotate the CRF (eCRF) according to the specifications.
- Create and assist in the data review guidelines, make sure to be consistent with the clinical data model, 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.
- May assist with the Lead Data Manager or Lead Data Reviewer to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary.
- Knowledge of Data Management tools, systems, and processes.
- Ensures service and quality, meet agreed upon specifications per the DMP and scope of work in the budget.
- Inform Lead Data Reviewer of overages in budgeted units and assist in Change Order Log process, if applicable.
- Perform quality control on data management activities as appropriate to include, but not be limited to all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved.
- Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team, as appropriate.
- Mentor / Coach in training of project staff on project-specific, global, standardized data management processes.
- Performs other related duties as assigned by management
Qualifications for Sr Clinical Data Specialist:
- University/college degree in life sciences, health sciences, or related subjects
- 4 to 6 years of Clinical Data Management experience
- Good organizational, communication, and interpersonal skills
- Preferred knowledge of medical terminology or science background
Physical Demands/Work Environment
Office and/or home-based work environment
