Job Details

Oversite of CRO

Data Management Planning: Develop and implement data management plans for CNS clinical trials, including data collection, cleaning, and validation strategies, in collaboration with the clinical development team.

Database Development: Collaborate with external vendors or internal teams to design and set up electronic data capture (EDC) systems and databases for clinical trials, ensuring they meet regulatory and company standards.

Data Entry and Verification: Oversee data entry and data verification activities to ensure accuracy, completeness, and consistency of clinical trial data.

Data Cleaning: Develop data cleaning procedures and perform ongoing data review to identify and resolve discrepancies or data quality issues. Implement data queries and coordinate resolution with site personnel.

Data Validation: Ensure data validation checks are programmed and executed to detect and address data anomalies promptly.

Data Locking: Lead the process of database lock, ensuring that all data management activities are completed on time and with high quality, in preparation for statistical analysis.

Data Standardization: Ensure data collected adheres to CDISC (Clinical Data Interchange Standards Consortium) standards for regulatory submissions.

Documentation: Maintain comprehensive documentation of data management activities, including data management plans, data cleaning reports, and audit trails, in compliance with regulatory requirements.

Compliance: Ensure compliance with relevant regulations (e.g., FDA, EMA, ICH guidelines) and company SOPs throughout the data management process.

Cross-functional Collaboration: Collaborate closely with clinical operations, biostatistics, and medical writing teams to support the overall success of clinical trials.

Vendor Management: Oversee and manage relationships with third-party data management vendors, if applicable.

Continuous Improvement: Identify and implement process improvements in data management procedures and tools to enhance efficiency and data quality.

Qualifications:

• Bachelor's degree in a related field (e.g., life sciences, computer science) required; advanced degree (e.g., Master's) preferred.
• Several years of experience in clinical data management within the biotech or pharmaceutical industry, with a focus on CNS therapeutic areas.
• Proficiency in using EDC systems and data management software (e.g., Medidata, Oracle InForm, Rave).
• Strong knowledge of regulatory requirements, including ICH-GCP guidelines, for clinical trial data management.
• Familiarity with CDISC standards and industry best practices.
• Excellent communication skills and the ability to work collaboratively in cross-functional teams.
• Strong attention to detail, organizational skills, and problem-solving abilities.
• Ability to adapt to changing priorities and work effectively in a dynamic environment.