Senior Clinical Data Manager

2 months ago

Lexington, United States Katalyst Healthcares & Life Sciences Full time

Responsibilities:
  • To responsible for study Data Management activities from study start up to close out.
  • To creates the data cleaning strategy and leads the data cleaning efforts supporting Clinical Studies.
  • Works 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 providing guidance on issues related to data management.
  • Responsible for study Data Management activities from study start up to close out.
  • Author Data Management timelines for assigned studies. Manage performance, quality, and timeliness of data from service providers (e.g., Central Reading Centre's, Labs, Medical Coders).
  • Data Management Documents: Author Data Management documentation (e.g. Data Management Plans, Data Review Guidelines and eCRF Completion Guidelines, and Study Timelines, etc.).
  • 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.
  • Data Review: 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. Database Build and User Acceptance Testing (UAT): Assist with the creation of the CRF and Edit Check Specifications documents. Perform User Acceptance Testing (UAT) of clinical databases including EDC.
  • EDC User Management: Manage EDC User Access for all assigned studies.
  • Collaboration with Cross-Functional Teams: Provide ongoing day-to-day support to the Clinical Study Teams to ensure all data is reviewed and discrepancies are resolved.
  • Collaborate with internal team 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.
  • Process Improvement: 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 process. Understanding of 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 ability to 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, and eCRF Completion Guidelines, and Study Timelines, etc.).
  • 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 creation of Case Report Forms and Edit Check Specifications.

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