Clinical Data Manager II

KEY RESPONSIBILITIES

• Author, review, and manage key study documentation including Data Management Plans, Project Plans, CRF Completion Guidelines, edit check specifications, and data review guidelines.
• Lead User Acceptance Testing (UAT) for clinical databases including EDC systems.
• Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming, and Regulatory teams.
• Oversee and manage delivery of EDC study deliverables against project timelines.
• Support and lead data cleaning efforts, conducting regular data reviews across assigned studies, identifying quality issues, trends, and outliers, and generating queries as needed.
• Represent Data Management in study team meetings, presenting data status metrics and providing guidance on data management issues.
• Perform review of study SAS and SDTM datasets to ensure data integrity and CDISC compliance.
• Provide input on and review of clinical data from external sources, supporting data reconciliation activities.
• Partner with programming to produce customized reports and data listings supporting data review, cleaning, and safety reviews.
• Generate ad hoc reports and data listings for study teams as requested.
• Assist with medical coding and AE/SAE reconciliation activities.
• Maintain CDM project documentation and vendor files in a complete, organized, and audit-ready state.
• Monitor and report on enrollment information collected in the clinical database.
• Assist with the development of Data Management training materials for Investigator meetings, in-house personnel, and site staff.
• Contribute to the ongoing development and improvement of departmental processes and procedures.

QUALIFICATIONS

Experience

• 2 to 5 years of relevant industry experience in Clinical Data Management required.
• Prior experience in the Pharmaceutical, Medical Device, Biotechnology, or CRO industry required.
• Experience in Ophthalmology therapeutic area preferred.
• Experience writing Data Management documentation such as DMPs and edit check specifications required.
• Project management experience required.
• Hands-on experience working with CDISC Standards (CDASH, SDTM) required.
• Experience with SQL, SAS, Excel, or other programming or data analysis tools a plus.

Technical Skills

• In-depth knowledge of FDA/ICH guidelines and industry standard practices for clinical data management.
• Hands-on working knowledge of EDC systems such as Inform, RAVE, iMedNet, or equivalent platforms.
• Proficiency with data review tools and the ability to analyze and interpret complex clinical datasets.
• Working knowledge of CDISC standards including CDASH and SDTM.

Core Competencies

• Excellent verbal and written communication skills with the ability to convey complex data concepts to cross-functional audiences.
• Strong project management and organizational skills with a track record of meeting study timelines.
• High attention to detail and a commitment to data quality and audit readiness.

Education

• BS or higher in Biological Science, Nursing, or a related health science discipline preferred.