Hollister Incorporated · 2 days ago
Specialist Clinical Data Management
Libertyville, IL
Full-time
Hybrid
Mid Level
$76K/yr - $107K/yr
3+ years expHollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The Specialist, Clinical Data Management (CDM) is responsible for leading all aspects of clinical data management for clinical studies, ensuring high data quality and compliance with regulatory requirements.
Health CareManufacturing
Responsibilities
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
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
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
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
Qualification
Required
3-5 years of overall experience necessary
Minimum of 3 years EDC database programming and Data Monitoring experience is required
Minimum of 2 years medical device and/or pharmaceutical clinical research experience or similar regulated industry is required
Bachelor's degree in life sciences, computer science, or related field
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)
Excellent oral and written communication skills
Strong interpersonal skills
Demonstrated ability to work independently, as well as part of a multifunctional study team
Ability to work on multiple concurrent studies and independently balance priorities to meet timelines
Preferred
Certified Clinical Data Manager (CCDM) via SCDM or similar preferred
Knowledge relating to continence care, critical care and/or ostomy a plus
Benefits
Paid time off programs
Peer-to-peer recognition
Health and life insurance
Wellness programs and incentives
Generous retirement savings
Participate in the Hollister Corporate Bonus Plan
Medical
Prescription
Dental
Vision
Spending/savings accounts
Disability
Company paid (parental and caregiver) leaves
Statutory leaves/disability programs
Accident
Life
Wellbeing
Education assistance
Adoption assistance
Voluntary benefit programs
401(k) Retirement Savings Plan includes: auto-enrollment, ROTH, vesting and eligible participants “safe harbor” matching contributions
11 paid holidays
Paid vacation based on length of service and exempt/non-exempt status
Sick days based on statutory requirements and/or exempt/non-exempt status
Education assistance and adoption assistance benefit programs
Company
Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide.
1001-5000 employees
H1B Sponsorship
Hollister Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (2)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Abinash Nayak
President and COO
scott holloway
Executive Vice President and Chief Commercial Officer
Recent News
Digital Music News
2026-01-06
2025-11-29
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