The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for Hollister Incorporated medical device products and services. The CDM leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The CDM regularly collaborates with Global Clinical Affairs (GCA) study team members (Clinical Project Management, Biostatistics, Clinical Operations, Clinical Scientist) and cross-functional departments to ensure high data quality. The position operates under minimal supervision and independently evaluates, selects, and applies data management practices to a variety of research projects.

This position is 4 days onsite in Libertyville, IL.

Design and Planning

• Lead the development of data management sections of clinical protocol and corresponding Case Report Forms (CRFs).
• Develop and maintain data management essential documentation for the Trial Master File including, but not limited to; Data Management Plan, study-specific monitoring guidelines, edit checks, and user access forms, ensuring compliance with regulatory requirements
• Support each clinical study and project team by ensuring data management plans, questionnaire development, and data handling activities are aligned to support the study objectives.
• Participate in study team meetings

Data Monitoring

• Monitor clinical data to resolve queries and data discrepancies throughout each study according to Clinical Protocol and/or Data Management Plan
• Coordinates AE/DD reconciliation with PI
• Identify and communicate data issues and/or query trends to study team and/or management.
• Assist with developing metrics on study progress and routinely report out to study team and management.

EDC Administration

• Design and program clinical study databases in EDC System including but not limited to CRFs, edit checks, data dictionaries, queries/alerts, and managing user roles based on the clinical protocol
• Lead User Acceptance Testing (UAT) to validate build specifications
• Train clinical research personnel on the study-specific CRF, EDC/ePRO, and other project related items as needed.
• Lead database clean, lock, export, and archiving activities.
• Oversee data management vendor relationships including EDC partners and CROs supporting DM tasks
• Continuously assess and enhance the EDC systems to improve efficiency and data quality

Compliance and Process

• Ensure data management activities comply with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures.
• Contribute to the maintenance of GCA's data management procedures and work instructions
• Responsible for leading or collaborating on process improvement initiatives within department
• Meet study timelines with a high degree of quality
• Other duties as needed or required.

• Minimum of 2 years medical device and/or pharmaceutical clinical research experience
• Certified Clinical Data Manager (CCDM) via SCDM or similar preferred
• Equivalent combination of education, training and work experience may be accepted in lieu of degree.
• Experience with EDC Systems (e.g. Medrio, Clinpal, Medidata Rave, etc.) required
• Understanding of clinical research regulations required
• Experience in questionnaire development, database structure, and data management processes
• Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams)
• Knowledge relating to continence care, critical care and/or ostomy a plus
• Minimum of 2 years EDC database programming and Data Monitoring experience