Clinical Data Management Leader for Oncology Biotech
1 week ago
This role is part of a Clinical Stage Oncology Biotech in San Diego, offering a unique opportunity to lead and manage the Clinical Data Management team.
Job Responsibilities- Foster a high-performance culture, promoting continuous learning and quality improvement within the Clinical Data Management team.
- Develop and implement data management strategies, including Case Report Forms (CRF) and electronic Trial Master Files (eTMF) design and management.
- Oversee the end-to-end data flow process for clinical trials, ensuring accuracy, consistency, and integrity.
- Manage Electronic Data Capture (EDC) systems implementation and use, adhering to regulatory requirements and industry best practices.
- Develop and maintain Standard Operating Procedures (SOPs) for data management activities, providing necessary training and guidance.
- Collaborate with cross-functional teams, aligning data management activities with clinical operations, biostatistics, and IT goals.
- Manage relationships with Contract Research Organizations (CROs), overseeing their data management activities and ensuring high-quality data delivery.
- Bachelor's degree in a scientific or related field, with an advanced degree preferred.
- Minimum 5 years of experience in clinical data management, with at least 3 years in a leadership role.
- ONCOLOGY experience is essential.
- Demonstrated expertise in EDC systems and related technologies.
- Strong knowledge of clinical trial processes and regulatory requirements.
- Experience in CRF and eTMF design and management.
- Proven ability to develop and implement data management strategies and SOPs.
- Experience managing CRO relationships.
- Excellent leadership and team management skills, with a track record of building high-performing teams.
- Strong problem-solving skills, with the ability to make data-driven decisions.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Proficiency in English, both written and spoken.
- Competitive base salary: $175,000 - $285,000 per year.
- Company-paid medical, dental, and vision coverage.
- 401k with company matching.
- Company Equity.
- PTO.
- Home office setup.
- Onsite gym with showers and towel service.
- Professional development opportunities.
- HYBRID opportunity: 3 days in office, 2 days at home.
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