Senior Clinical Data Manager

About the role

The Senior Clinical Data Manager is responsible for study Data Management activities from study start up to close out. They create the data cleaning strategy and lead the data cleaning efforts supporting Clinical Studies, working in coordination with Data Management, Biostatistics, and Clinical Operations teams to develop standard operating processes in support of clinical research.

Responsibilities

• Represent Data Management in study team meetings, providing data status metrics and guidance on data management issues.
• Author Data Management timelines for assigned studies.
• Manage performance, quality, and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders).
• Author Data Management documentation (e.g., Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, Study Timelines).
• Create Data Management training materials for Investigator Meetings, in-house personnel, and site staff.
• Maintain Data Management project documentation, including vendor files, in an audit-ready manner.
• Assist 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 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 Clinical Study Teams to ensure data review and discrepancy resolution.
• Collaborate with internal teams and stakeholders to meet deliverable timelines.
• Work with Clinical Programming to produce additional reports outside of Data Review Guidelines.
• Facilitate cross-functional Data Management meetings with Study Managers, Clinical Study Teams, Project Managers, Programming, and Regulatory.
• Generate reports or data listings for study teams as needed.
• Review Protocols and provide feedback on data collection-related items.
• Participate in the review and update of Data Management standard operating procedures, work instructions, and templates.
• Contribute to the development of departmental processes and procedures.

Requirements

• Minimum of 5 years of experience in clinical data management, preferably in the pharmaceutical or medical device industry.
• Understanding of the clinical trial process and FDA/ICH guidelines.
• Knowledge of Good Clinical Data Management Practices (GCDMP) and other regulatory guidelines specific to data management.
• Hands-on experience with Electronic Data Capture (EDC) systems (e.g., MedNet, Rave, Veeva Vault EDC).
• Ability to review data using various reporting and analytics tools.
• Strong project management, multitasking, and problem-solving skills.
• Experience writing Data Management documentation (e.g., Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines).
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a team environment.
• Knowledge of CDISC Standards (CDASH, SDTM).
• Ability to manage multiple clinical studies at different stages of activity.
• Flexibility in responding to changing 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.

Desirable Skills

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