Senior Clinical Data Manager – Trials & Data Integrity

Planet Pharma; San Diego (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

Planet Pharma in San Diego, CA is seeking a Principal Data Manager to lead data management for clinical trials partnering with CROs or internal teams. You will ensure data quality, integrity, and regulatory compliance across studies.

The role drives data management deliverables, oversees vendor relationships, and contributes to SOPs and study protocols from a data management perspective. Strong leadership and collaboration are essential.

Qualifications

• Demonstrated knowledge of drug development and Clinical Data Management processes.
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology.
• Understanding of ICH Guidelines and GCP Requirements.
• Excellent communication skills and interpersonal skills.
• Experience in managing outsourced studies and/or leading CRO data management teams.

Responsibilities

• Act as the single point of accountability for data management deliverables at an assigned level within a given clinical development program.
• Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to data management.
• Manage data management deliverables when sourced internally.
• Oversee system integrations across data platforms.
• Review CRO and vendor data outputs and file in the Trial Master Plan as appropriate.
• Perform ongoing data review to identify discrepancies and resolutions.
• Review protocol deviations and dictionary coding; perform UAT of the database.
• Create data management specifications, transfer agreements, and workflow diagrams.

Skills

Data leadership

CDM oversight

Cross-functional collaboration

Regulatory knowledge

ICH/GCP familiarity

AI for productivity

Timeline planning

Vendor management

Communication

Tools

Medidata RAVE

EDC platforms

Data management tools

Job description

Planet Pharma in San Diego, CA is seeking a Principal Data Manager to lead data management for clinical trials partnering with CROs or internal teams. You will ensure data quality, integrity, and regulatory compliance across studies.

The role drives data management deliverables, oversees vendor relationships, and contributes to SOPs and study protocols from a data management perspective. Strong leadership and collaboration are essential.