Verismo Therapeutics · 1 day ago
Director of Clinical Data Management
Philadelphia, PA
Full-time
Hybrid
Director/Executive
10+ years expVerismo Therapeutics is a company focused on bringing life-changing cell therapies to cancer patients. They are seeking a motivated and experienced Director of Clinical Data Management to oversee clinical data management activities, ensuring high quality and reliable clinical trial data.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Oversee the collection, validation and processing of clinical trial data
Develop and implement data management procedures for clinical trials
Support and facilitate the review of medical coding for validity and completeness
Ensure compliance with applicable regulations, protocols and standard operating procedures
Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock
Stay updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management
In conjunction with the Senior Director, DM, the Director DM contributes to and supports the strategic direction of the Clinical Data Management functional area and ensures activities and processes support the efficient and effective execution of clinical trials
Support the development of standards, provide system oversight support, and support digital security strategies as well as drive/support audit/inspection readiness activities
Oversee and be responsible for activities related to outsourcing of DM activities. Specifically, ensure establishment of relevant processes to ensure oversight of data management vendor partners to empower high quality standards and performance
Work in close collaboration with other functional areas within Verismo’s Research organization to support cohesive end to end DM processes across vendors
Drive work order review activities within the data management area and support program budget oversight activities
Qualification
Required
Bachelor's degree in science or related area (or equivalent)
10+ years of experience in clinical data management experience in biotech/ pharma industry; significant end-to-end, hands-on experience in all aspects of data management
Significant experience working with clinical trials and the drug development process
Significant experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities, and analysis and reporting in complex oncology trials
Significant experience leading data management activities for clinical trials; advanced use of data management systems; expert knowledge of DM processes, tools, methodologies, and documentation; expert understanding of DM strategy
Significant experience of GCPs, SOPs, regulatory requirements, and good data management practices
Significant experience with CDISC (SDTM) as well as data collection requirements in oncology trials
Experience in developing and implementing data management procedures for clinical trials while maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock
Up-to-date on industry best practices, technological advancements, and regulatory requirements related to clinical data management
Preferred
Master's or Advanced Degree preferred
Experience with all phases of oncology trials preferred
Company
Verismo Therapeutics
Verismo Therapeutics is a biotechnology company that develops CAR T cell therapy for the treatment of solid tumors.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$44.2MKey Investors
Institute for Follicular Lymphoma InnovationScaleReadyBRV Capital Management
2025-01-07Seed· $4.05M
2024-12-20Acquired
2024-09-17Grant· $0.15M
Leadership Team
Michael Milone
Founder
Recent News
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