Senior Clinical Data Manager
1 week ago
We are seeking a highly skilled Clinical Data Management Specialist to join our team at Katalyst Healthcares and Life Sciences. As a key member of our Clinical Data Management team, you will be responsible for overseeing data management activities from study start-up to close-out, ensuring the quality and timeliness of data from service providers, and developing and managing study timelines.
Key Responsibilities- Represent Data Management in study team meetings, providing metrics and guidance on data-related issues.
- Develop and manage study timelines, ensuring the quality and timeliness of data from service providers.
- Author key documents, including Data Management Plans, Data Review 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.
- 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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