Clinical Data Manager

Support Groundbreaking Pharmaceutical Research

Join a dedicated Clinical Data Management team supporting clinical studies in the rare disease and pharmaceutical space. This role offers the opportunity to apply clinical data management expertise to directly support impactful projects that make a meaningful difference to patients worldwide.

Primary Responsibilities

The successful candidate will play a key part in ensuring clinical data is accurate, compliant, and ready for analysis. You will collaborate with vendor project managers, clinical data managers, CROs, and cross-functional study teams to maintain high-quality data standards.

• Act as the primary data management contact for assigned studies, representing the function on project teams and partnering with CROs.
• Coordinate and lead clinical data management activities in alignment with company SOPs, policies, and regulatory requirements.
• Oversee CRO data clean-up from study start-up through data archiving to ensure data quality and integrity.
• Manage medical coding, data validation checks, database snapshots, and provide data for analysis.
• Create and maintain study documentation, including the Data Management Manual, CRF completion guidelines, and validation specifications.
• Design and modify CRFs, and oversee the build, testing, and validation of clinical databases.
• Prepare and distribute project status reports to project teams and management.
• Lead the data management team in ensuring databases are validated and ready for transfer and analysis, while supporting standardization of outsourcing partner processes.

Skills and Requirements

• Bachelor's degree in mathematics, science, or a related field.
• Experience in clinical data management within biotechnology, pharmaceuticals, or a health-related industry.
• Strong ability to coordinate and manage CRO data managers and project teams, ensuring adherence to policies and procedures.
• Solid understanding of data management processes, database validation, and regulatory compliance.
• Excellent collaboration, organizational, and communication skills.
• Preferred experience in genetics, oncology, and/or ophthalmology.