Senior Clinical Data Manager

• 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 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.

• 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.

How will you get here?

• Minimum of 5 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. MedNet, 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
• 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 preemptively identify data and system issues and mitigate risks to data quality.
• Bachelor’s degree in a relevant scientific or technical discipline.

• Familiarity with Ophthalmology Therapeutic area
• Experience with creation of Case Report Forms and Edit Check Specifications.

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