Job Details
Posted 17 August, 2026
Job Id: 630137
Clinical Data Management Specialist
Job Description
Summary
The Specialist, Clinical Data Management (CDM) is a leader in supporting clinical studies for 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.
Responsibilities
Design and Planning
- Lead the development of data management sections of clinical protocol and corresponding Case ReportForms (CRFs).
- Develop and maintain data management essential documentation for the Trial Master File including, but notlimited 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, questionnairedevelopment, and data handling activities are aligned to support the study objectives.
- Participate in study team meetings
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 asneeded.
- 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
Data Monitoring
- Monitor clinical data to resolve queries and data discrepancies throughout each study according to ClinicalProtocol 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.
- Compliance and Process
- Ensure data management activities comply with Good Clinical Practice (GCP), regulatory requirements, andinternal 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.
Essential Functions of the Role
- Communicate effectively via email, phone, and virtual platforms.
- Prepare reports and dashboards for internal stakeholders.
- Ensure data accuracy and confidentiality in compliance with company and legal standards.
- Manage multiple priorities and deadlines in a fast-paced environment.
- Demonstrate initiative in identifying process improvements or automation opportunities.
- Serve as a point of contact for internal and external stakeholders.
- Resolve inquiries and issues with professionalism and discretion.
- Adhere to company policies, including those related to ADA, data privacy, and ethics.
- Maintain secure handling of sensitive information.
Education & Work Requirements
- Bachelor’s Degree with 2-5 years of related experience
Education & Work Preferences
- Minimum of 2 years EDC database programming and Data Monitoring experience
- 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
Competencies
- Be Agile – Innovates and adapts quickly, approaching change with curiosity while persisting throughobstacles.
- Be Customer Centric – Considers the needs, experiences and feedback of customers in all we do.
- Be People-Focused – Builds trust and collaborates with an inclusive and empathetic approach.
- Be Performance Driven – Operates with an ownership mindset, driving meaningful outcomes.
- Live The Schneiders’ Legacy, Our Noble Purpose – Passionately serves Our Mission and Vision, whiledemonstrating the Immutable Principles.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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