Director of Clinical Data Management
Why Join Verismo?
Our team is small but driven, with the single focus of bringing life-changing cell therapies to patients with cancer. With a solid pipeline built around a novel KIR-CAR platform, and two clinical trials underway, our technology has found a way to circumvent the barriers in solid cancer where other CAR therapies have limited success. KIR-CARs eliminate the artificial chimeric constructs within T cells and instead use a natural NK cell derived signaling system. This system is potent against both hematologic and solid tumors, and in preclinical models is superior to current CAR T in conferring long-term sustained anti-tumor function to overcome the challenges posed in solid cancer. We have a strong team for CMC, clinical product manufacture, and clinical investigators already established and moving fast to bring KIR-CARs to patients in need.
Our company is comprised of individuals who each bring something unique to the table and are valued for their contributions. Our culture is based on the concept of ‘love what you do’ and the dedication that builds a team where people do their best and support one another. Because we believe our people are our greatest asset, career development is an important aspect of our investment in our team and we encourage work/life balance.
About the Position:
Verismo Therapeutics is seeking a motivated and experienced Director of Clinical Data Management to join our energetic and high-growth team. This individual will report directly to the Senior Director of Clinical Data Management. The position is responsible for the oversight of Clinical Data Management activities related to the effective planning and timely delivery of complete, high quality, and reliable clinical trial data. The Director, DM will provide oversight to ensure that end-to-end data management activities are consistent across the studies within the portfolio. The ideal candidate should have extensive knowledge of the clinical data management principles, regulatory guidelines, and industry best practices. They should be willing to work independently and collaboratively with cross-functional teams to ensure timely and accurate data delivery.
Essential Duties & Responsibilities:
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Oversee the collection, validation and processing of clinical trial data.
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Develop and implement data management procedures for clinical trials.
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Support and facilitate the review of medical coding for validity and completeness.
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Ensure compliance with applicable regulations, protocols and standard operating procedures.
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Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock.
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Stay updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management.
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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.
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Support the development of standards, provide system oversight support, and support digital security strategies as well as drive/support audit/inspection readiness activities.
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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.
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Work in close collaboration with other functional areas within Verismo’s Research organization to support cohesive end to end DM processes across vendors.
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Drive work order review activities within the data management area and support program budget oversight activities.
Requirements:
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Bachelor's degree in science or related area (or equivalent); Master’s or Advanced Degree preferred
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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.
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Experience with all phases of oncology trials preferred
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Significant experience working with clinical trials and the drug development process
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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
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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
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Significant experience of GCPs, SOPs, regulatory requirements, and good data management practices
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Significant experience with CDISC (SDTM) as well as data collection requirements in oncology trials
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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.
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Up-to-date on industry best practices, technological advancements, and regulatory requirements related to clinical data management.