Clinical Data Manager

Jobtailor; New Jersey; On-site; USD 85,000 - 120,000; Full time

Job summary

Jobtailor is seeking a Data Manager to support clinical research studies in New Jersey. You will handle data management activities, CRF design, and database specifications, ensuring compliance with SOPs and regulatory guidelines.

You will review study protocols, perform UAT, generate reports, and mentor staff while collaborating with cross-functional teams to resolve data issues and ensure data quality.

Qualifications

• Undergraduate degree in math, CS, or life sciences or equivalent.
• 3+ years supporting clinical studies in data management or analytics.
• Understanding of database design and cross-functional needs.
• Knowledge of regulatory requirements and ICH/GCP guidelines.
• Experience with eClinical systems and data reporting tools.
• SQL and SAS basics are preferred.

Responsibilities

• Support data management activities for research studies per SOPs and guidelines.
• Review study protocols and provide input on design and data capture.
• Design and develop case report forms (CRFs).
• Develop database specifications and edit checks.
• Maintain the Data Management Plan and CRF completion guidelines.
• Perform User Acceptance Testing and data review.
• Identify deviations, adverse events, and data trends for resolution.
• Generate study reports and assist in monitoring visits prep.
• Maintain study data in eTMF and train staff on CDMS systems.
• Contribute to DM SOPs, instructions, and cross-functional meetings.
• Mentor junior associates and support audits and quality checks.

Skills

Data Management

Project Management

Analytical Skills

Communication

Education

Bachelors in Math/CS/LifeSciences

Tools

Medidata RAVE

Oracle Clinical

Veeva

OpenClinica

Medrio

Job description

• Support all data management activities for research studies in compliance with departmental SOPs and regulatory guidelines
• Review and provide input to study protocols
• Design and develop case report forms (CRFs)
• Develop database specifications and edit check specifications
• Develop and maintain the Data Management Plan
• Develop CRF Completion Guidelines
• Perform User Acceptance Testing
• Conduct data review, query generation and resolution, and third-party data reconciliation
• Identify and review protocol deviations and adverse events
• Identify data trends and resolve data management issues with study personnel and cross-functional teams
• Generate study reports and reports for internal validation and cross-validation studies
• Assist CRAs with preparation for monitoring visits
• Maintain study data, reports, and documentation in the electronic Trial Master File (eTMF)
• Train internal and external personnel in CDMS systems, technology, applications, and data management processes
• Contribute to DM SOPs, Business Guidance, Work Instructions, and Standards
• Attend project and functional group meetings
• Perform routine audits of study files and records
• Provide mentoring and coaching to new hires and junior associates as needed

Requirements

• Undergraduate degree in a Math, Computer Science, or Life Sciences field required or equivalent combination of education, training and industry related experience
• 3 or more years’ experience supporting clinical research studies within a data management, data analytics, or a data reporting function
• Understanding of database design, data structure, design constraints and cross-functional needs to support clinical trials
• Working knowledge of the clinical research process and regulatory requirements
• Knowledge of data management processes and industry standards
• Experience with Electronic Data Capturing Systems such as Medidata RAVE, Oracle Clinical, Veeva, OpenClinica, iMedNet, or Medrio required
• Knowledge and experience with clinical data reporting tools such as JReview
• Knowledge and skill in using Microsoft Office suite
• Understanding of ICH, ISO, GCP, and GDP guidelines
• Effective project management, analytical, problem-solving, interpersonal, verbal, written communication, organizational, and time management skills
• Ability to work independently with minimal supervision
• Ability to work within cross-functional and highly matrixed teams
• Ability to adapt to changing priorities
• Basic knowledge of SQL preferred
• Basic understanding of SAS concepts preferred

Core Competencies

Demonstrates expertise in data management for clinical research, including database design, data reporting, and compliance with regulatory guidelines. Proficient in using Electronic Data Capturing Systems and skilled in project management and communication within cross-functional teams.

Highest-signal resume keywords

• Data Management
• Electronic Data Capturing Systems
• Clinical Research Process
• Project Management
• Database Design

Hard Skills

• Database Design
• Data Management Processes
• SQL
• SAS Concepts
• Data Reporting
• User Acceptance Testing
• Case Report Forms Development
• Data Review
• Query Generation
• Adverse Events Identification

Soft Skills

• Analytical Skills
• Problem-Solving
• Interpersonal Skills
• Verbal Communication
• Organizational Skills

Industry Keywords

• ICH Guidelines
• ISO Standards
• GCP Guidelines
• GDP Guidelines
• Clinical Trials

Tools & Technologies

• Medidata RAVE
• Oracle Clinical
• Veeva
• OpenClinica
• IMedNet
• Medrio
• Microsoft Office Suite
• JReview