Sr. Clinical Data Manager
Katalyst Healthcares & Life Sciences
Danbury, CTContractor
Behavioral Health Market Context
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Qualifications
- •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
- •9 more items(s)
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
- •16 more items(s)
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