Senior Clinical Data Manager

• Provide a high level of expertise in Data Management (DM) to support clinical studies.
• Ensure that data quality and integrity are maintained from study start through database lock.
• Lead the design of CRFs/eCRF for sound and thorough data collection through the regulatory approval process.
• Lead data review, query management, and data management metrics reporting to ensure completeness, correctness, and consistency.
• Assume data management responsibility for multiple clinical trials, including specification and testing of the Electronic Data Capture (EDC) and other data collection systems.
• Author and maintain data management documents including Data Management Plans, Data Transfer Plans, and Data Review Plans.
• Review study protocols and assist in the planning and implementation of the data management portions.
• Data Management Lead for assigned clinical studies.
• Serves as an active member of Clinical Study Teams (CST).
• Works with other functions to develop timelines and ensure that clinical data management deadlines are met.
• Oversees DM CROs as applicable.
• Works with vendors such as central laboratories in support of timelines and data-related deliverables.
• Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
• Defines eCRF and edit check specifications as necessary to support data collection and analyses required by the protocol.
• Works closely with database builders during programming of EDC databases, edit checks and reports.
• Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications.
• Develops study-specific eCRF Completion Guidelines.
• Creates and follows study-specific Data Management Plans.
• Creates and maintains data management documentation.
• Ensures data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
• Works with the appropriate coding group to ensure medical terminology coding is applied to assigned clinical studies.
• Helps design listings in support of clinical and medical review of data.
• Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
• Trains other personnel on eCRFs and EDC, as needed.
• Coordinates with cross-functional team members on serious adverse event reconciliation.
• Provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required.
• May participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
• Other duties as assigned.

Requirements

• Bachelor's degree in a scientific subject area preferred
• Minimum 9 years of clinical data management experience in biotechnology or pharmaceutical industry
• Minimum 6 years of Electronic Data Capture (EDC) experience; IXRS development preferred
• Proficient computer skills, including Microsoft Office applications
• Must have strong knowledge of Data Management processes and systems
• Solid understanding of clinical drug development processes required
• Must have demonstrated problem solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment
• Excellent written and verbal communication skills are required
• Experience and understanding of ICH, GCP and CDASH/CDISC are required
• Experience with Medidata Rave preferred
• Experience with illuminate®, or comparable analytics software preferred
• Familiar with MedDRA and WHO Drug coding
• Experience participating in regulatory submissions and inspections a plus