Kumquat Biosciences Inc. · 2 hours ago
Senior Manager, Clinical Data Management
San Diego,CA,US
Full-time
Onsite
Senior Level, Lead/Staff
$175K/yr - $198K/yr
8+ years expKumquat Biosciences Inc. is a small biotech company seeking a Senior Manager for Clinical Data Management. This role involves overseeing end-to-end data management activities for clinical studies, ensuring high-quality datasets that support program milestones and regulatory submissions.
Alternative MedicineBiotechnologyOncologyTherapeutics
Responsibilities
Serve as the CDM lead for one or more clinical programs, accountable for overall data quality, timelines, documentation, and deliverables
Represent Data Management in study teams, Biometrics, Clinical Operations, and Regulatory meetings
Provide expertise and oversight of all clinical database activities from design/start-up to closeout
Reviews protocols for appropriate data capture including electronic (eCRF) design
Support CRF design, review, and validation of clinical database
Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing
Conducts oversight of data management vendors via ongoing review of quality and performance metrics
Generates, resolves, and tracks data queries to ensure the integrity of the clinical data
Facilitates and participates in data cleaning activities
Generates and/or reviews/approves study documents
Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness
Proactively identifies potential data management issues/risks and communicates it within the study team for further action
Ensure all CDM activities comply with GCP, ICH guidelines, company SOPs, and regulatory requirements
Contribute to development and continuous improvement of data standards, processes, and templates
Support audit/inspection readiness activities and respond to data-related findings
Qualification
Required
Bachelor's or Master's degree in Life Sciences, Computer Science, Statistics, or health-related field
8+ years of hands-on clinical data management experience, ideally in oncology
Strong expertise in EDC systems (Rave, Veeva, or similar) and hands-on database build & UAT
Proven track record in small biotech or fast-paced environments with significant operational responsibility
Experience with vendor oversight and management of external data sources
Demonstrated ability to lead database locks and deliver clean, inspection-ready datasets
Strong interpersonal skills, collaborative mindset, and ability to thrive in a lean, resource-constrained organization
Preferred
Oncology experience strongly preferred (Phase 1/2)
Experience with programming or data visualization tools (SAS, R, Spotfire) a plus
Experience in implementing data standards and process optimization at small biotech
Prior experience supporting regulatory submissions (NDA, BLA, MAA) is an advantage
Company
Kumquat Biosciences Inc.
Kumquat Biosciences’ vision is to develop innovative therapies to bring about sustainable and life-changing benefits to cancer patients.
11-50 employees
H1B Sponsorship
Kumquat Biosciences 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 (2)
2024 (2)
2023 (1)
2022 (2)
2021 (2)
Funding
Current Stage
Early StageTotal Funding
$175.92MKey Investors
Loxo Oncology
2021-07-29Corporate Round· $70M
2021-02-16Undisclosed· $50M
2019-07-02Private Equity· $55.92M
Leadership Team
Pingda Ren
Co-Founder, President & COO
Carin Sandvik
VP of Finance
Recent News
Labiotech.eu
2025-09-12
2025-08-17
Company data provided by crunchbase