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.

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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data managementdatabase designdata cleaningdata quality oversightUser Acceptance Testingdata standards implementationregulatory submissionsdata visualizationprogrammingdata query resolution

Soft Skills

interpersonal skillscollaborative mindsetleadershipproblem-solvingcommunicationorganizational skillsrisk identificationadaptabilityattention to detailproactive approach