The Clinical Data Manager will be responsible for managing and overseeing the collection, validation, and analysis of clinical trial data. They will also be responsible for ensuring the quality and accuracy of the data throughout the entire trial process.
Responsibilities
Develop and implement data management plans and procedures for clinical trials
Oversee the collection and validation of clinical trial data
Ensure data quality and accuracy through data review, query resolution, and data cleaning
Work with cross-functional teams, including biostatistics, clinical operations, and medical writing
Ensure compliance with regulatory and industry standards
Participate in the development of clinical study protocols and case report forms
Manage data transfer and reconciliation between different systems
Generate study-specific data management reports
Provide input into the development of project timelines and resource planning
Maintain knowledge of relevant industry and regulatory guidelines
Develop and maintain data management standards and best practices
Qualifications
Bachelor's degree in a life science or related field
Minimum of 3 years of experience as a Clinical Data Manager in the biopharmaceutical industry
Familiarity with CDISC standards and guidelines
Knowledge of clinical trial design and statistical analysis
Experience with Electronic Data Capture (EDC) systems
Knowledge of regulatory guidelines, including FDA and ICH guidelines
Excellent analytical and problem-solving skills
Strong written and verbal communication skills
Ability to work independently as well as in a team environment
Strong attention to detail and accuracy
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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