What Does a Clinical Data Manager Do?
A clinical data manager ensures the quality and integrity of data collected during clinical trials. They develop data management plans, oversee database setup, and monitor the flow of trial data to ensure it’s accurate, consistent, and compliant with regulatory standards. Their work is essential for supporting the safety and efficacy evaluation of new drugs, treatments, or medical devices.
Working closely with clinical researchers, biostatisticians, and regulatory teams, clinical data managers manage systems that capture and clean patient data. From initial trial setup to final database lock, they serve as data stewards, ensuring that critical information is ready for submission to regulatory agencies.
Looking to Hire a Clinical Data Manager?
Speak with one of our recruiting experts today.
Clinical Data Manager Core Responsibilities
- Develop and implement data management plans for clinical trials
- Design, test, and maintain electronic data capture (EDC) systems
- Create and validate case report forms (CRFs)
- Review and clean data by identifying discrepancies and issuing queries
- Collaborate with clinical operations, biostatistics, and regulatory teams
- Maintain data integrity and ensure adherence to protocols and compliance standards (e.g., ICH-GCP, FDA, EMA)
- Prepare data sets for interim and final analyses
- Document processes and maintain audit-ready records
Required Skills and Qualifications
Hard skills
- Proficiency with clinical data systems (e.g., Medidata Rave, Oracle Clinical, REDCap)
- Understanding of CDISC standards, clinical trial design, and regulatory requirements
- Data cleaning and query resolution techniques
- SQL, SAS, or other data analysis tools familiarity
Soft skills
- Detail-oriented with strong analytical skills
- Effective written and verbal communication
- Problem-solving and decision-making under regulatory pressure
- Collaborative mindset across cross-functional teams
Educational requirements
- Bachelor’s degree in life sciences, health informatics, or related field
- Master’s degree preferred for advanced or leadership roles
Certifications
- Certification in clinical data management (e.g., CCDM from SCDM) preferred but not required
Preferred Qualifications
- Experience managing data from multi-site or global trials
- Background in oncology, rare disease, or device studies
- Familiarity with regulatory submission standards (e.g., eCTD, CDASH)
- Exposure to audit processes or regulatory inspections
National Average Salary
Clinical data manager salaries vary by experience, industry, organization size, and geography. Click below to explore salaries by local market.
The average national salary for a Clinical Data Manager is:
$97,085
Sample Job Description Templates for Clinical Data Managers
Entry-Level Clinical Data Manager
Position Overview
An entry-level clinical data manager supports clinical research studies by managing and validating trial data under supervision. They assist in database setup, query management, and quality control tasks, ensuring data is complete and accurate throughout the study lifecycle.
Responsibilities
- Assist with the development and testing of electronic data capture (EDC) systems
- Generate and track data queries to resolve discrepancies
- Support the creation and maintenance of case report forms (CRFs)
- Perform data cleaning and coding in accordance with study protocols
- Help maintain data documentation and audit trails
- Collaborate with senior data managers and clinical teams on ongoing trials
Requirements
Hard skills
- Familiarity with EDC tools (e.g., Medidata Rave, REDCap)
- Basic understanding of ICH-GCP and clinical trial processes
- Strong Excel or database skills
- Awareness of data standards (e.g., CDISC, CDASH)
Soft skills
- Detail-oriented and methodical
- Willingness to learn in a regulated environment
- Strong communication and organizational skills
- Ability to follow detailed procedures
Education
- Bachelor’s degree in life sciences, health informatics, or related field
Certifications
- CCDM certification not required but encouraged for career advancement
Senior Clinical Data Manager
Position Overview
A senior clinical data manager leads the data management function for multiple clinical trials. They are responsible for data strategy, vendor oversight, and ensuring all data is accurate, compliant, and submission-ready.
Responsibilities
- Manage clinical data activities from database setup to database lock
- Lead development of CRFs and data management plans (DMPs)
- Oversee query generation, resolution timelines, and data cleaning
- Collaborate with biostatistics, clinical operations, and regulatory teams
- Supervise and mentor junior data managers or contractors
- Ensure adherence to SOPs, GCP, and sponsor/CRO guidelines
Requirements
Hard skills
- Advanced experience with clinical data platforms (e.g., Oracle Clinical, Medidata Rave)
- Regulatory knowledge (e.g., FDA, EMA, eCTD)
- Data export preparation for analysis and submissions
- Vendor management and team leadership
Soft skills
- Strong problem-solving and decision-making abilities
- Cross-functional communication
- Time management for multiple studies
- Quality focus and accountability
Education
- Bachelor’s or master’s degree in a scientific or data-focused discipline
Certifications
- CCDM or equivalent strongly preferred
Lead Clinical Data Manager
Position Overview
The lead clinical data manager drives strategy and oversight across multiple clinical programs or large-scale trials. They provide direction to data teams, manage stakeholder expectations, and ensure the accuracy, compliance, and submission-readiness of clinical trial data.
Responsibilities
- Lead cross-study data strategy and planning across clinical programs
- Oversee database design, UAT testing, and CRF standardization
- Manage timelines, resources, and risk mitigation for data deliverables
- Act as primary data liaison with sponsors, CROs, and regulatory stakeholders
- Prepare teams for audits and ensure inspection-readiness
- Coach, train, and evaluate junior and senior data team members
Requirements
Hard skills
- Expert-level knowledge of data systems, regulatory requirements, and CDISC standards
- Experience in late-phase trials and regulatory submissions
- Strategic vendor and timeline management
- Knowledge of EDC integrations and analytics platforms
Soft skills
- Executive communication and leadership presence
- Strategic mindset with attention to operational detail
- Conflict resolution and mentorship skills
- Proactive stakeholder engagement
Education
- Bachelor’s degree required; master’s preferred in scientific or technical discipline
Certifications
- CCDM or equivalent certification required