Sr. Clinical Data Manager
Katalyst Healthcares and 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).
- uthor 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.
- ssist 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.
- 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.
- bility to manage multiple clinical studies and tasks simultaneously.
- Knowledge of CDISC Standards (CDASH, SDTM).
- Problem-solving skills and flexibility in responding to business needs.
- bility to identify and mitigate risks to data quality proactively.
- Experience in ophthalmology therapeutic areas.
- Familiarity with Case Report Form and Edit Check Specification development.
Vacancy posted 1 day ago
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