Clinical Data Manager II

Clinical Data Manager II South San Francisco, CA 12 Months'

Location:

Hybrid 3 days onsite/ 2 days WFH

Job Description:

Data Manager/Data Quality Leader Reporting Functionality

Function:

US Medical Affairs

Sub-function:

Evidence Generation / Data Systems

Reports To:

DM Manager

Direct Reports:

None

Position Summary:

The Data Manager within the US Medical Affairs Data Management function will operate as part of a team specializing in data lifecycle management. This team is responsible for acquiring and curating data to support exploratory research, clinical development, and evidence generation. The role requires collaboration with peers within the function and across the organization to identify, design, and execute fit-for-purpose data management solutions, ensuring alignment with FAIR principles (Findable, Accessible, Interoperable, Reusable). The individual will be responsible for ensuring timely completion of data management deliverables and will work closely with Functional Service Providers (FSPs), Data Management CROs, and other vendors by providing oversight and technical expertise to ensure delivery of high-quality data. Additionally, the role contributes to functional, cross-functional, enterprise-wide, and external initiatives that influence the organization's technical landscape, business operations, and the broader healthcare environment. This position requires strong strategic thinking, collaboration, and communication skills, along with an entrepreneurial mindset to evolve how data is collected and delivered in support of developing medicines for patients.

Job Level Description:

The Data Management Lead will contribute to the development of new concepts, technologies, and standards. In addition to demonstrating strong proficiency in core data management activities (with the ability to work independently with minimal supervision), the individual will provide leadership and strategic direction to Data Management team members and adapt strategies to meet evolving program objectives.

Role:

Data Quality Leader - Key Tasks (including but not limited to): Collaborate with internal teams and cross-functional stakeholders to identify, design, and implement fit-for-purpose data management solutions, ensuring adherence to FAIR principles Serve as a subject matter expert in data collection and acquisition, advising stakeholders on best practices and proposing innovative approaches, including handling new data types (e.g., biomarkers), technologies (e.g., sensors), and data sources (e.g., EMR) Partner with and oversee data management deliverables (e.g., Task Ownership Matrix) from Functional Service Providers (FSPs) and vendors, providing quality assurance to ensure high-quality data and compliance with applicable pharmaceutical regulations and standards Proactively manage timelines and track key decisions to ensure successful execution of the study scope of work (SOW) delivered by FSPs, while maintaining accountability for data quality and providing technical and business support where needed Oversee sample management and eManifest processes, ensuring timely and proactive resolution of queries Conduct high-level data reviews using graphical visualizations, statistical monitoring tools, and standard metrics to identify outliers, trends, gaps in programmed checks, or unexpected data anomalies Represent BDS Data Management on Study Management Teams (SMTs) and participate in relevant meetings such as Data Quality meetings, as required Proactively engage with stakeholders across the organization and biometrics teams to understand business needs and influence decision-making within the function Collaborate with relevant functions for external data vendor selection and management, including overseeing development of data transfer agreements that ensure use of standards, appropriate data models, and defined transfer intervals Contribute to functional, cross-functional, enterprise-wide, and external initiatives that shape the future data and technology landscape

Major Responsibilities:

Project Management Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies and projects, including the adoption and implementation of new technologies Stakeholder Management Engage proactively with stakeholders across the organization to understand their needs, influence decision-making, communicate key deliverables, and respond to changing milestones Vendor Management Support vendor selection and management activities, including oversight of data transfer agreements to ensure adherence to standards, fit-for-purpose data models, and defined transfer schedules Data Collection and Acquisition Act as a subject matter expert in data collection methodologies, advising stakeholders on best practices and ensuring high-quality data compliant with applicable regulations and standards Data Solutions Remain current with emerging tools and technologies related to data collection, management, visualization, and analytics to deliver effective and fit-for-purpose solutions Data Quality Review data surveillance tools and methodologies to perform aggregate-level reviews, identifying patterns, anomalies, and data quality issues to ensure accurate and reliable outcomes Data Curation Organize and integrate data from multiple sources while maintaining its usability and value through adherence to FAIR principles Support Analyses Collaborate with stakeholders to understand data insight requirements and provide appropriate data management solutions, with a strong understanding of the data lifecycle from collection through analysis and submission (if applicable) Functional Excellence Contribute to cross-functional initiatives and continuous improvement efforts, supporting adoption of innovative technologies and enhancing data utilization across the organization Technical Consultant Provide guidance and expertise to internal teams, stakeholders, FSPs, CROs, and collaborators on technical solutions to ensure high-quality data collection and delivery

Minimum Qualifications:

Bachelor's or Master's degree in Life Sciences, Data Science, Computer Science, Bioinformatics, or equivalent industry experience Strong collaboration and communication skills, both written and verbal (English proficiency required) Knowledge of CDISC data standards Understanding of ICH-GCP and experience working in regulated environments Project management skills Ability to manage multiple priorities effectively Demonstrated leadership, decision-making, negotiation, motivation, and influencing skills Experience with data analytics and/or visualization tools Entrepreneurial mindset, self-driven attitude, and willingness to learn and mentor others Understanding of biological concepts and data types (e.g., clinical, biomarker, genomics such as WGS and RNA-seq) Preferred /

Additional Qualifications:

Experience leading data management activities across multiple complex clinical studies from start-up through close-out Experience in clinical trial data and/or real-world data collection Understanding of disease areas, molecule development strategies, and the healthcare environment Extensive technical or industry experience (for senior/principal roles) Experience with enterprise systems and database technologies Programming skills in SAS, R, Python, SQL, or similar languages Familiarity with advanced analytics techniques such as machine learning and AI Experience working with large datasets and distributed computing tools (e.g., Hadoop, Spark) Experience creating interactive data outputs (e.g., Shiny, Tableau) Contribution to open-source tools or libraries Experience with reproducible research practices (e.g., version control, literate programming) Experience with CDISC standards such as SDTM and CDASH Familiarity with MedDRA and WHODrug Relevant healthcare qualifications (e.g., BSN, RN, RPh, PharmD, PA) preferred

Job Competencies:

Strategic Agility / Teamwork and Collaboration Demonstrates cultural awareness and respect when working with diverse, global teams Strategic Agility Possesses a foundational understanding of the healthcare environment, including regulatory requirements, payer systems, and medical practices, as they relate to data reporting Technical & Business Expertise - Clinical Data Management Demonstrates knowledge and experience in data management across the full lifecycle of clinical studies, from start-up through database lock Technical & Business Expertise - Industry Standards Understands and applies

CDISC/CDASH

standards and complies with regulations such as HIPAA and GDPR; stays informed on emerging data technologies and sources (e.g., EDC, ePRO, EMR, claims data, telemedicine) Innovation Contributes to development and enhancement of business processes and technical solutions Teamwork & Collaboration Applies project management skills to manage scope, delegate tasks, and oversee data management activities across internal teams and external vendors Communication & Influence Exhibits strong interpersonal, consulting, and communication skills, with the ability to influence stakeholders and build effective cross-functional relationships Achieving Results Demonstrates initiative, problem-solving ability, and adaptability in dynamic environments, with a focus on delivering results Independence Capable of working with minimal supervision while meeting role expectations Feedback & Coaching Shows willingness and ability to mentor and support the development of other data management professionals #TB_PH #ZRHC Why TalentBurst? At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.