Currentjob openings

Director Clinical Data Management

Position Summary:    

Reporting to the head of data science, the Director Clinical Data Management will utilize strategic input and hands on technical expertise to support clinical data management across the Erasca portfolio. They will represent CDM on program teams and partner with cross-functional study and program teams to deliver high quality and reliable clinical trial data for study readouts, internal decision-making, external presentation, and regulatory submission.  

Essential Duties & Responsibilities: 

• Provide CDM operational input for the direction, planning, execution, collection, and handling of all clinical data to the highest quality standard while ensuring compliance with industry standards and Erasca reporting requirements 
• Serve as the DM representative on cross-functional study teams and program teams and on the Data Science leadership team
• Continue to develop and operationalize SOPs, standards, and templates for CDM, utilizing industry knowledge and best practices 
• Lead and manage a high performing team
• Provide oversight and management of outsourced CDM activities, including timeline, budget, and performance management; ensure vendor compliance with ICH guidelines, applicable clinical trial regulations, and SOPs 
• Author and/or review and approve study-related documents and plans, including CRFs, database design, data validation specifications, data management plans, coding specifications, data reconciliation plans, data transfer agreements, CRF completion guidelines, site training materials, etc. to ensure the quality of data collection and review 
• Monitor data quality metrics, data trends, and data issues; issue queries and lead data cleaning activities by working closely with cross functional teams; provide accurate and timely updates to leadership, partners, and stakeholders 
• Proactively identify, communicate, and manage risks that may affect clinical program milestones, quality, or budget 
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations 

Required Skills & Experience: 

• 8 or more years of clinical data management or closely related experience in the Biotechnology or Pharmaceutical industry 
• Undergraduate degree required; advanced degree in Computer Science, Mathematics, Statistics or related field a plus; CCDM certification a plus 
• Experience working in a dynamic startup or small company environment preferred 
• Extensive experience in clinical data management for early and late stage drug development 
• Oncology experience preferred, or experience across multiple therapeutic areas and phases of development with demonstrated ability to come up to speed in new areas 
• Experience prioritizing work across a broad portfolio of assets and studies 
• Vendor management experience 
• Expertise with GCDMP, CDISC data standards, 21 CFR Part 11, GDPR and other industry regulations and submissions requirements; knowledge of FDA and ICH regulations and industry standards for data capture and data management process 
• Exposure to inspection and submission readiness required; experience supporting NDA or similar submission preferred 
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment; a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex problems  
• Strong learning orientation, curiosity, and passion for science and patients