Clinical Data Manager II

Job Title: Clinical Data Manager II
Location: South San Francisco, CA 94080
Duration: 12-Month Contract (Potential for Extension or Conversion)
Pay Rate: $41.88 - $80.90/hour (W2)
Benefits: Weekly pay, Medical, Dental, and Vision coverage
Hybrid 3 days onsite/ 2 days WFH

Position Overview
We are seeking a Clinical Data Manager II / Data Quality Leader to join the US Medical Affairs Data Management team. This role focuses on end-to-end data lifecycle management, supporting exploratory research, clinical development, and evidence generation.
The ideal candidate will collaborate cross-functionally to design and implement scalable, high-quality data solutions aligned with F.A.I.R. (Findable, Accessible, Interoperable, Reusable) principles. This role also includes oversight of vendors and ensuring timely, compliant delivery of data management activities.
 
Key Responsibilities
Data Management & Strategy

• Design and execute fit-for-purpose data management solutions aligned with FAIR principles
• Lead data collection strategies, including emerging data types (e.g., biomarkers, EMR, sensor data)
• Contribute to new concepts, standards, and technologies in data management

Data Quality & Oversight

• Ensure high-quality, compliant data through quality checks and regulatory adherence
• Perform data reviews using visualizations, statistical tools, and trend analysis
• Identify anomalies, gaps, and inconsistencies in datasets

Vendor & Stakeholder Management

• Oversee Functional Service Providers (FSPs), CROs, and external vendors
• Manage data deliverables, timelines, and quality expectations
• Support vendor selection and data transfer agreement development

Project & Study Management

• Manage timelines, risks, and deliverables for assigned studies
• Track decisions and ensure successful execution of study scope
• Represent Data Management in study team meetings and data quality forums

Data Operations

• Oversee sample management and eManifest processes
• Ensure proper data integration and curation from multiple sources
• Support downstream analysis by maintaining high-quality datasets

Collaboration & Innovation

• Partner with cross-functional teams to understand data needs and deliver solutions
• Drive adoption of new tools, technologies, and data practices
• Contribute to enterprise-wide initiatives and process improvements

 
Major Responsibility Areas

• Project Management: Timeline oversight, risk mitigation, and delivery execution
• Stakeholder Management: Engagement, communication, and alignment on deliverables
• Vendor Management: Oversight of external partners and data standards compliance
• Data Collection & Acquisition: Best practices and innovative data sourcing
• Data Quality Review: Monitoring, validation, and anomaly detection
• Data Curation: Integration and maintenance using FAIR principles
• Technical Consulting: Provide expertise to internal teams and external partners

 
Minimum Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Data Science, Bioinformatics, or related field
• Strong communication and collaboration skills (written and verbal)
• Knowledge of CDISC standards and ICH-GCP guidelines
• Experience in regulated environments and clinical data management
• Project management and multitasking abilities
• Leadership, decision-making, and stakeholder influencing skills
• Experience with data analytics and visualization tools

 
Preferred Qualifications

• Experience leading data management activities for clinical studies
• Knowledge of Real-World Data (RWD) and clinical trial data collection
• Proficiency in programming (SAS, R, Python, SQL)
• Experience with advanced analytics (AI/ML) and large datasets (Hadoop, Spark)
• Familiarity with tools like Tableau, Shiny, or similar visualization platforms
• Knowledge of MedDRA, WHODrug, SDTM, and CDISC implementation
• Experience with reproducible research practices and version control
• Background in healthcare or clinical professions (RN, PharmD, etc.) preferred

 
Core Competencies

• Strategic thinking and adaptability
• Strong teamwork and cross-functional collaboration
• Technical expertise in clinical data management
• Knowledge of industry standards and regulatory compliance
• Effective communication and stakeholder influence
• Results-driven mindset with problem-solving ability
• Mentorship and leadership capabilities