Senior Manager, Clinical Data Management at Kumquat Biosciences Inc

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Apr, 26

Salary

198000.0

Posted On

23 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Data Quality, EDC Systems, Database Build, Vendor Oversight, Data Cleaning, Regulatory Submissions, Problem Solving, Attention to Detail, Interpersonal Skills, Collaboration, Oncology Experience, Data Standards, Process Optimization, User Acceptance Testing, Data Visualization

Industry

Biotechnology Research

Description

Description The Senior Manager, Clinical Data Management (CDM) will oversee and execute end-to-end data management activities for early- and late-phase clinical studies in a fast-paced, small-biotech environment. This role requires a blend of strategic leadership and hands-on operational responsibilities to ensure high-quality, inspection-ready clinical datasets that support program milestones, regulatory submissions, and critical decision-making. The ideal candidate is proactive, detail-oriented, and comfortable rolling up their sleeves to perform data management tasks while also managing CROs/vendors and providing strategic oversight. Candidates with qualification/experience of one level above or below this role may also be considered. Key Responsibilities Leadership & Oversight 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. Hands-On Data Management Execution 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. Requirements 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. Characteristics for Success Hands-on, proactive, accountable—comfortable doing the work, not just delegating. Ability to manage competing priorities across multiple studies. Strong problem-solver with excellent attention to detail. Effective communicator who builds strong cross-functional partnerships. Enjoys working in a nimble, entrepreneurial biotech environment. Salary Description: $175k - $198k

Responsibilities

The Senior Manager will oversee end-to-end data management activities for clinical studies, ensuring high-quality datasets that support program milestones and regulatory submissions. This includes leading data management efforts, managing CROs, and executing hands-on data management tasks.