Senior Clinical Data Manager

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• 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.

Requirements:

• Bachelor's degree or higher in biological science, nursing, or a related health field preferred.
• Minimum of 7 years of experience in clinical data management, preferably within the pharmaceutical or medical device industry.
• Strong understanding of clinical trial processes, FDA/ICH guidelines, and Good Clinical Data Management Practices (GCDMP).
• Hands-on experience with Electronic Data Capture (EDC) systems such as MedNet, Rave, and Veeva Vault EDC.
• Proficiency in data review and use of reporting/analytics tools.
• Excellent project management and documentation skills, with experience writing Data Management Plans, Data Review Guidelines, and study timelines.
• Strong verbal and written communication skills.
• Ability to manage multiple clinical studies and tasks simultaneously.
• Knowledge of CDISC Standards (CDASH, SDTM).
• Problem-solving skills and flexibility in responding to business needs.
• Ability to identify and mitigate risks to data quality proactively.
• Experience in ophthalmology therapeutic areas.
• Familiarity with Case Report Form and Edit Check Specification development.

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