Senior Clinical Data Manager

Data Management Specialist

Represent Data Management in study team meetings, providing metrics and guidance on data-related issues.

Oversee Data Management activities from study start-up to close-out.

Develop and manage study timelines and ensure the quality and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders).

Author key documents, including Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, and study timelines.

Prepare training materials for Investigator Meetings, internal teams, and site staff.

Maintain all Data Management project documentation in an audit-ready manner.

Support Lead Clinical Programmers in developing and managing Data Transfer Agreements.

Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed.

Reconcile data from external sources.

Assist in creating CRF and Edit Check Specifications.

User Acceptance Testing (UAT) of clinical databases, including EDC systems.

Manage EDC User Access for all assigned studies.

Provide day-to-day support to Clinical Study Teams to ensure data is reviewed and discrepancies are resolved.

Collaborate with internal stakeholders to meet study timelines and deliverables.

Work with Clinical Programming to produce reports for efficient data review and cleaning.

Facilitate cross-functional Data Management meetings with Study Managers, Project Managers, Programming, and Regulatory teams.

Review study protocols and provide feedback on data collection methods.

Participate in updating Data Management standard operating procedures, work instructions, and templates.

Contribute to the development and improvement of departmental processes.