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

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