Head of Clinical Data Management

Eikon Therapeutics; Millbrae (CA); Hybride; USD 178 000 - 215 000; Plein temps

Avantages offerts par ce poste

401k plan with company matching

Medical, dental, and vision insurance

Mental health and wellness benefits

Paid time off and holidays

Résumé du poste

Eikon Therapeutics, a pioneer in real-time cellular data, seeks an Associate Director of Clinical Data Management. The role drives strategic leadership and oversees data collection, EDC system design, and QA across studies in a hybrid work model with NJ or CA offices.

You will guide cross-functional teams, ensure regulatory compliance, and advance data integrity from collection through analysis, leveraging cutting-edge tools and industry best practices.

Qualifications

• Post graduate degree with 8+ years of relevant experience or a Bachelor's degree with 10+ years.
• Extensive experience in clinical data management, including data collection, database design, and quality assurance.
• In-depth understanding of biotech/pharma industry data management practices and regulatory guidelines.

Responsabilités

• Provide strategic direction and leadership for the clinical data management team.
• Develop and implement data collection strategies, tools, and systems for study goals and regulatory requirements.
• Oversee data quality control processes, including validation, discrepancy management, and reconciliation.
• Lead the design and maintenance of electronic data capture (EDC) systems or databases.
• Ensure adherence to data standards and regulatory guidelines throughout the lifecycle.
• Collaborate with biostatisticians, clinicians, and regulatory experts to enable data integration and analysis.
• Maintain documentation of processes, decisions, and workflows.
• Mentor and develop team members to sustain high performance.

Connaissances

Leadership

Data management

Regulatory knowledge

EDC systems

Data standards

Cross-functional collaboration

Analytical skills

Problem solving

Oncology experience

Veeva EDC

Formation

Postgraduate degree

Bachelor's degree

Outils

Veeva EDC

Description du poste

Eikon Therapeutics, a pioneer in real-time cellular data, seeks an Associate Director of Clinical Data Management. The role drives strategic leadership and oversees data collection, EDC system design, and QA across studies in a hybrid work model with NJ or CA offices.

You will guide cross-functional teams, ensure regulatory compliance, and advance data integrity from collection through analysis, leveraging cutting-edge tools and industry best practices.