What are the responsibilities and job description for the Clinical Data Manager II position at Advanced Clinical?
We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Data Manager II in South San Francisco, California (Hybrid, 3 days onsite per week). The Clinical Data Manager II will operate within the U.S. Medical Affairs Data Management function, supporting data lifecycle activities for exploratory research, clinical development, and evidence generation. This role will drive high-quality data delivery by designing and implementing fit-for-purpose data management solutions aligned with FAIR (Findable, Accessible, Interoperable, Reusable) principles. Their work will have a direct impact on data quality, regulatory compliance, and the advancement of healthcare insights, making this a highly strategic career opportunity.
RESPONSIBILITIES
Data Management & Quality Oversight
• Design and execute data management solutions aligned with FAIR data principles
• Act as a subject matter expert in data collection, acquisition, and integration across diverse data sources (e.g., clinical, biomarker, EMR, real-world data)
• Provide oversight and quality assurance for data management deliverables from Functional Service Providers (FSPs), CROs, and vendors
• Ensure high-quality data and compliance with industry regulations and standards (e.g., ICH-GCP, CDISC)
• Perform high-level data review using visualization tools and statistical monitoring techniques to identify trends, outliers, and anomalies
• Oversee sample management and eManifest processes, ensuring timely issue resolution
Project & Stakeholder Management
• Proactively manage timelines, risks, and deliverables to ensure successful study execution
• Serve as the Data Management representative on study management teams and governance forums
• Collaborate cross-functionally with stakeholders to understand data needs and influence decision-making
• Provide clear communication and reporting on project status, risks, and deliverables
Vendor & Systems Management
• Partner with internal teams to support vendor selection and oversee external data vendor performance
• Manage data transfer agreements, ensuring use of appropriate standards, models, and transfer intervals
• Stay current with emerging data technologies, tools, and platforms to enhance data collection and delivery
Data Strategy & Continuous Improvement
• Contribute to enterprise-wide and cross-functional initiatives to improve data systems, processes, and technologies
• Support development of innovative approaches to data collection, management, and analysis
• Promote adoption of new tools, standards, and best practices across the organization
EXPERIENCE
Minimum of 5–8 years of experience in data management, clinical data, or related field required
Demonstrated experience leading or supporting data management activities across clinical studies required
Experience working with FSPs, CROs, and external vendors required
Strong understanding of data standards (e.g., CDISC, SDTM) and regulatory requirements (ICH-GCP) required
Experience with data analytics, visualization tools, and/or programming languages (e.g., SAS, R, Python, SQL) preferred
Experience with real-world data, biomarkers, or advanced analytics (AI/ML) preferred
EDUCATION
Minimum of a Bachelor’s or Master’s Degree in Life Sciences, Data Science, Computer Science, Bioinformatics, or a related discipline required
To be a best-fit your strengths must include:
• Strong expertise in data lifecycle management within a regulated environment
• Excellent project management and organizational skills with the ability to manage multiple priorities
• Strong analytical and problem-solving capabilities with attention to detail
• Ability to translate complex data needs into actionable solutions
• Strong stakeholder management and cross-functional collaboration skills
• Excellent written and verbal communication skills
• Ability to influence without authority and drive alignment across teams
• Entrepreneurial mindset with a focus on innovation and continuous improvement
• Commitment to data quality, integrity, and compliance
RESPONSIBILITIES
Data Management & Quality Oversight
• Design and execute data management solutions aligned with FAIR data principles
• Act as a subject matter expert in data collection, acquisition, and integration across diverse data sources (e.g., clinical, biomarker, EMR, real-world data)
• Provide oversight and quality assurance for data management deliverables from Functional Service Providers (FSPs), CROs, and vendors
• Ensure high-quality data and compliance with industry regulations and standards (e.g., ICH-GCP, CDISC)
• Perform high-level data review using visualization tools and statistical monitoring techniques to identify trends, outliers, and anomalies
• Oversee sample management and eManifest processes, ensuring timely issue resolution
Project & Stakeholder Management
• Proactively manage timelines, risks, and deliverables to ensure successful study execution
• Serve as the Data Management representative on study management teams and governance forums
• Collaborate cross-functionally with stakeholders to understand data needs and influence decision-making
• Provide clear communication and reporting on project status, risks, and deliverables
Vendor & Systems Management
• Partner with internal teams to support vendor selection and oversee external data vendor performance
• Manage data transfer agreements, ensuring use of appropriate standards, models, and transfer intervals
• Stay current with emerging data technologies, tools, and platforms to enhance data collection and delivery
Data Strategy & Continuous Improvement
• Contribute to enterprise-wide and cross-functional initiatives to improve data systems, processes, and technologies
• Support development of innovative approaches to data collection, management, and analysis
• Promote adoption of new tools, standards, and best practices across the organization
EXPERIENCE
Minimum of 5–8 years of experience in data management, clinical data, or related field required
Demonstrated experience leading or supporting data management activities across clinical studies required
Experience working with FSPs, CROs, and external vendors required
Strong understanding of data standards (e.g., CDISC, SDTM) and regulatory requirements (ICH-GCP) required
Experience with data analytics, visualization tools, and/or programming languages (e.g., SAS, R, Python, SQL) preferred
Experience with real-world data, biomarkers, or advanced analytics (AI/ML) preferred
EDUCATION
Minimum of a Bachelor’s or Master’s Degree in Life Sciences, Data Science, Computer Science, Bioinformatics, or a related discipline required
To be a best-fit your strengths must include:
• Strong expertise in data lifecycle management within a regulated environment
• Excellent project management and organizational skills with the ability to manage multiple priorities
• Strong analytical and problem-solving capabilities with attention to detail
• Ability to translate complex data needs into actionable solutions
• Strong stakeholder management and cross-functional collaboration skills
• Excellent written and verbal communication skills
• Ability to influence without authority and drive alignment across teams
• Entrepreneurial mindset with a focus on innovation and continuous improvement
• Commitment to data quality, integrity, and compliance
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.
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