Specialist Clinical Data Management

About the role

The Specialist, Clinical Data Management (CDM) supports clinical studies for Hollister Incorporated medical device products and services. Key responsibilities include designing and planning data management sections of clinical protocols, leading UAT, overseeing EDC systems, and monitoring data quality.

Responsibilities

• Design and plan data management sections of clinical protocols and CRFs.
• Develop and maintain essential documentation for the Trial Master File.
• Collaborate with study teams to ensure alignment of data management plans and project activities.
• Administer EDC systems, including database design, UAT, and user training.
• Manage data management vendors and oversee database clean-up, lock, export, and archiving.
• Maintain compliance with GCP and regulatory requirements.
• Monitor clinical data, resolve queries, and communicate issues to the study team and management.
• Contribute to process improvement initiatives.

Requirements

• Bachelor's Degree with 2-5 years of related experience.
• Minimum 2 years EDC database programming and Data Monitoring experience.
• Minimum 2 years medical device and/or pharmaceutical clinical research experience.
• CCDM certification via SCDM or similar preferred.
• Experience with EDC Systems (e.g. Medrio, Clinpal, Medidata Rave, etc.).
• Understanding of clinical research regulations.
• Experience in questionnaire development, database structure, and data management processes.
• Experience with Microsoft Suite Applications (Word, PowerPoint, Excel, Teams).
• Knowledge of continence care, critical care, and/or ostomy.

Qualifications

• Effective communication via email, phone, and virtual platforms.
• Ability to prepare reports and dashboards for internal stakeholders.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Initiative in identifying process improvements or automation opportunities.
• Professionalism and discretion in resolving inquiries and issues.
• Adherence to company policies, including ADA, data privacy, and ethics.
• Secure handling of sensitive information.

Skills

• Able to adapt quickly to change.
• Customer-centric approach in all interactions.
• People-focused collaboration and inclusivity.
• Performance-driven mindset towards achieving goals.
• Compliance with company policies and ethical standards.

Benefits

• Competitive base pay range of $77,000 - $120,000 yearly.
• Health and welfare benefits including medical, prescription, dental, vision, and life insurance.
• Paid time off programs, including 11 paid holidays, paid vacation, and sick days.
• Retirement savings plan with auto-enrollment, ROTH options, and safe harbor matching contributions.
• Education and adoption assistance programs.

About Hollister Incorporated

Hollister Incorporated develops, manufactures, and markets healthcare products worldwide. The company focuses on ostomy care, continence care, and critical care, and provides educational support materials for patients and healthcare professionals. Based in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.