Clinical Data Management Leader for Oncology Biotech

1 week ago


San Diego, California, United States Jobot Full time
Job Overview

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.
Requirements
  • 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.
What We Offer
  • 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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