Sr Clinical Data Specialist(EDS)

Job Overview:

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. Potential to assist in development of project Data Management Plan, including data review guidelines / set-up of the data management systems according to project requirements. Potential to serve as the operational data management leader – as a Lead Data Reviewer, on small projects with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, project timelines and budgets.

Summary of Responsibilities:

• 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.
• 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 (Minimum Required):

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).
• Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.

Experience (Minimum Required):

• 4 to 6 years of Clinical Data Management.
• Some knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
• Time management skill and ability to adhere to project productivity metrics and timelines.
• Ability to work in a team environment and collaborate with peers.
• Good organizational ability, communication, and interpersonal skills.
• Team working skills and good collaborator skills.
• Knowledge of medical terminology is preferred.
• Knowledge of science or a scientific background is preferred.
• Good oral and written communication skills.

Preferred Qualifications Include:

• Through knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs).
• Two or more years of Electronic Data Capture experience.
• Knowledge of Fortrea and the overall structure of the organization.

Physical Demands/Work Environment:

• Office and/or home-based work environment.

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