Senior Clinical Data Manager

Katalyst Healthcares & Life Sciences • Lexington, KY, United States • $200k - $250k / year • 1m ago

Responsibilities:

Responsible for study Data Management activities from study start-up to close-out.
Create the data cleaning strategy and lead the data cleaning efforts supporting Clinical Studies.
Work in coordination with Data Management, Biostatistics, and Clinical Operations teams to develop standard operating processes in support of clinical research.
Represent Data Management in study team meetings, providing data status metrics and guidance on issues related to data management.
Author Data Management timelines for assigned studies. Manage performance, quality, and timeliness of data from service providers (e.g., Central Reading Centres, Labs, Medical Coders).
Author Data Management documentation (e.g., Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, and Study Timelines).
Author Data Management training materials used for Investigator Meetings, in-house personnel, and site staff.
Maintain Data Management project documentation, including vendor files, in an audit-ready manner.
Assist the Lead Clinical Programmers with the creation and maintenance of Data Transfer Agreements.
Lead and perform regular data review across studies to identify quality issues, data trends/outliers, and generate queries as necessary.
Review and reconcile data from external sources.
Assist with the creation of the CRF and Edit Check Specifications documents. Perform User Acceptance Testing (UAT) of clinical databases including EDC.
Manage EDC User Access for all assigned studies.
Provide ongoing day-to-day support to the Clinical Study Teams to ensure all data is reviewed and discrepancies are resolved.
Collaborate with internal teams and stakeholders to ensure deliverables meet timelines.
Work with Clinical Programming to produce additional reports outside of the Data Review Guidelines to facilitate efficient data review and cleaning.
Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming, and Regulatory.
Generate reports or data listings for study teams as needed.
Review Protocol and provide feedback to the Clinical Study Team on data collection-related items.
Participate in the review and update of the Data Management standard operating procedures, work instructions, and templates.
Participate in the development of departmental processes and procedures.

Requirements:

BS or higher in biological science, nursing, or other health-related discipline preferred.
Minimum of 8 years of experience working in clinical data management, preferably in the pharmaceutical or medical device industry.
Understanding of clinical trial processes, FDA/ICH guidelines, and industry/technology standard practices.
Understanding of Good Clinical Data Management Practices (GCDMP) and other regulatory guidelines specific to data management.
Hands-on working knowledge of Electronic Data Capture (EDC) systems (e.g., Med Net, Rave, Veeva Vault EDC, etc.).
Hands-on ability to review data and use various reporting and analytics tools.
Multi-tasking, problem-solving, and verbal and written communication skills essential.
Project Management experience writing Data Management documentation (e.g., Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, and Study Timelines).
Excellent verbal and written communication skills. Ability to work well with others.
Knowledge of CDISC Standards (CDASH, SDTM).
Ability to effectively manage a variety of data management tasks for multiple clinical studies and different stages of activity.
Flexibility in responding to change or business needs. Proven ability to pre-emptively identify data and system issues and mitigate risks to data quality.
Desirable: Familiarity with Ophthalmology Therapeutic area. Experience with the creation of Case Report Forms and Edit Check Specifications.

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