Associate Director, Clinical Data Management – Oncology

SimulStat Incorporated; United States; Hybrid; USD 140,000 - 190,000; Full time

Job summary

SimulStat Incorporated is seeking a senior Clinical Data Manager to lead day-to-day data activities across early- and late-stage studies in a hybrid Redwood City setting.

You will mentor staff and oversee CROs and vendors, drive data standards, QC, and regulatory compliance (ICH/GCP/FDA), and collaborate with cross-functional teams to deliver clean, ready-for-analysis datasets.

Qualifications

• 11+ years of clinical data management experience in early- and/or late-stage trials.
• Hands-on with EDC systems and data standards (MedDRA/WHODrug).
• Strong knowledge of ICH, GCP, and FDA regulations.
• Proven CRO/vendor oversight and leadership.
• Preferred oncology experience and 5+ years of direct line management.

Responsibilities

• Lead day-to-day clinical data management across studies and set strategy.
• Liaise with CROs, EDC vendors, and third-party data vendors; review proposals.
• Author or review CRFs; oversee EDC build, UAT, maintenance, and lock/unlock.
• Own Data Management Plans, study timelines, and status reporting to cross-functional teams.
• Manage data cleaning and reconciliation, including queries, SAE reconciliation, coding, and deviations.
• Support data listings, table validation, data specs, and data transfers ahead of audits.
• Drive data standardization across programs and contribute to SOP development.
• Mentor and manage internal data management staff.

Skills

Leadership

Cross-functional collaboration

Vendor oversight

Regulatory knowledge

Communication

Education

BS/BA or MS in relevant field

Tools

EDC systems

QC/audit tools

Job description

Hybrid (3 days on-site in Redwood City, CA office) 12-month contract

Responsibilities

• Lead day-to-day clinical data management activities across early- and late-stage studies, and set the data management strategy for each study
• Serve as primary liaison with CROs, EDC vendors, and third-party data vendors; review CRO proposals and oversee outsourced studies and deliverables
• Author or review CRFs and CRF completion guidelines; oversee EDC database build, UAT, maintenance, and lock/unlock
• Own Data Management Plans, study timelines, and status reporting to cross-functional teams
• Manage data cleaning and reconciliation, including query management, SAE reconciliation, external vendor data reconciliation, medical coding, and protocol deviation tracking
• Support data listings, table validation, data specifications, and data transfers ahead of statistical review and audits
• Drive data standardization across programs and contribute to SOP development and department initiatives
• Mentor and manage internal data management staff

Qualifications

• BS/BA or MS in a relevant scientific or technical field
• 11+ years of industry clinical data management experience supporting early- and/or late-stage trials
• Hands-on experience with EDC systems, clinical data standards, medical coding dictionaries (MedDRA/WHODrug), and QC/audit processes
• Working knowledge of ICH, GCP, and FDA regulations
• Proven track record of CRO and vendor oversight
• Strong leadership, communication, and cross-functional collaboration skills
• Preferred: oncology experience (solid tumors) and 5+ years of direct line management