Summit Therapeutics, Inc. · 1 day ago
Senior Manager, Clinical Data Management
Palo Alto, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$174K/yr - $204K/yr
8+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The Senior Manager of Clinical Data Management will oversee clinical data management activities for oncology trials, ensuring data integrity and quality across multiple studies.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Lead and manage clinical data management activities for multiple oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards
Provide strategic oversight and direction to CRO clinical data management teams for assigned studies
Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements
Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality
Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes
Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals
Lead the selection, oversight, and performance management of external data management vendors
Develop and maintain SOPs, guidelines, and best practices for clinical data management processes
Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters
Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field
All other duties as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred
A minimum of 8+ years of clinical data management experience in the biotechnology or pharmaceutical industry, with at least 3+ years in a leadership role
Extensive experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges
Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming
Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards
Demonstrated experience in CRO and vendor oversight
Excellent project management skills with the ability to manage multiple studies simultaneously
Strong analytical and problem-solving skills with meticulous attention to detail
Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders
Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus
Preferred
CCDM® (Certified Clinical Data Manager) certification
Experience with risk-based monitoring in oncology studies
Knowledge of emerging technologies in clinical data collection and management (e.g., ePRO, wearables, AI/ML applications)
Preference will be given to candidates who can work a hybrid schedule at our Menlo Park, CA office
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
201-500 employees
H1B Sponsorship
Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M
Leadership Team
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
2025-12-09
2025-12-05
Company data provided by crunchbase