Summit Therapeutics, Inc. · 16 hours ago
Associate Director, Clinical Data Management
Palo Alto, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$174K/yr - $204K/yr
10+ years expSummit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The Associate Director, Clinical Data Management will lead data management for clinical trials, ensuring data quality and compliance while managing a team and collaborating with various stakeholders.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Provide expertise and contribute to the strategy and development of the Clinical Data Management Portfolios to ensure data quality in support of clinical study data milestones and deliverables
Lead and support establishment of systems and processes to help ensure clinical data security, integrity, and long-term goals of the business function, in alignment with company priorities
Leads the data management of overall drug development process with early and late phase clinical trials in large or complex development program(s)
Provides technical expertise to develop and implement clinical data standards, data management plans, data transfer agreements, and data flow processes to ensure timely and quality data delivery for analysis purpose
Oversees the process to identify, evaluate and select CROs, vendors and technology for CDM activities
Leads, designs and/or oversees eCRF design, eCRF specifications, eCRF completion guidelines, annotated CRFs, User Acceptance Testing, query logic, edit checks, data query resolution, SAE reconciliation between clinical and pharmacovigilance databases, vendor data reconciliation & cleaning, data migration and database closeout for clinical trials
Represents Data Management and promotes productive collaboration with other functions (e.g., Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Translational Science, Project Management, Regulatory, QA, and IT) to ensure proper alignment around data management activities & deliverables, operational excellence, compliance with regulations, policies, procedures, and clinical objectives
Supports cross functional teams and studies to handle data management questions, troubleshoot, help resolve issues and mitigate risks. Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams and studies
Works with the Director of Clinical Data Science (CDS) to enhance efficiency, optimize costs, and drive excellence
Works with the Director of Clinical Data Science to establish CDM processes and procedures including SOPs to ensure highest data quality/integrity/security and regulatory. compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices
Leads clinical data management activities during regulatory audits, ensuring compliance with industry standards and regulations, and providing expert input throughout the audit process
Works with the Head of Statistical Programming & CDS to manage departmental budget and execute resource planning across multiple projects
Works with the Director of Clinical Data Science to provide oversight and guidance, as well as establish key performance metrics with CROs to ensure the highest data quality/integrity and regulatory compliance
Accommodate ad hoc data requests between clinical team members, scientists, and vendors to support data cleaning, data entry requirements and exploratory data review if needed
Uses scientific and drug development knowledge to anticipate and mitigate data management-related challenges during clinical trial execution
Reviews and contributes to clinical protocols and amendments, study manuals, and other study conduct related clinical documents; review clinical data according to these documents
All other duties as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience
A minimum of 10+ years of Clinical Data Management experience (oncology experience highly desirable) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of the MedDRA and WHODRUG coding processes
Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants
Excellent interpersonal, communication, and leadership skills
Consistent, detail oriented, communicative, dedicated to do a job well done
Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Preferred
CRO and vendor oversight experience preferred
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 Chief Financial Officer
Recent News
Company data provided by crunchbase