Clinical Data Manager
Overview:
In this remote, contract role you will lead clinical data management activities to ensure accurate, compliant data for analysis. You'll partner with CROs and cross-functional teams to uphold data quality and regulatory standards. Your work drives reliable datasets for meaningful patient-focused research in rare diseases and pharma. This position offers scale, impact, and collaboration within a specialized clinical data function.
Responsibilities:
- Serve as the primary data management contact for assigned studies and coordinate with CROsLead CDM activities aligned with company SOPs and regulatory requirements
- Oversee CRO data cleanup from study start-up to archiving to ensure quality and integrity
- Manage medical coding, data validation checks, database snapshots, and provision of data for analysis
- Create and maintain study documentation (Data Management Manual, CRF guidelines, validation specs)
- Design/modify CRFs and oversee build, test, and validation of clinical databases
- Prepare and distribute project status reports to teams and management
- Lead the CDM team to ensure validated databases ready for transfer and analysis; support outsourcing partner process standardization
Key requirements:
- Bachelor's degree in mathematics, science, or related field
- Experience in clinical data management within biotechnology, pharmaceuticals, or health-related industry
- Strong ability to coordinate and manage CRO data managers and project teams
- Solid understanding of data management processes, database validation, and regulatory compliance
- Excellent collaboration, organizational, and communication skills
- Preferred experience in genetics, oncology, and/or ophthalmologycollaborationorganizational skillsclear communicationclinical data managementdatabase validationregulatory compliance