Clinical Data Manager II

SQA Solution; South San Francisco (CA); Hybrid; USD 76,000 - 117,000; Full time

Job summary

South San Francisco, CA-based biotech company seeks a Clinical Data Manager II to lead data life-cycle management, ensuring timely delivery and high-quality, compliant data across vendors.

You will collaborate with internal teams, DM CROs and FSPs, applying FAIR data principles, guiding data collection, quality reviews and data provisioning using SAS, R, Python and SQL in a regulated environment.

Qualifications

• BS or MS in Life Sciences, Data/CS, Bioinformatics or equivalent industry experience.
• 5-10 years of relevant work experience in data management or clinical data.
• Knowledge of CDISC data standards and ICH-GCP in regulated environments.
• Experience with data analytics and/or visualization tools.
• Familiarity with EDC systems and handling clinical/real-world data.
• Experience with SAS, R, Python, SQL and big data tools preferred.

Responsibilities

• Develop risk management strategies and oversee study delivery.
• Engage stakeholders and inform milestones.
• Vendor management for data vendors and data transfers.
• Advise on data collection and best practices.
• Deliver fit-for-purpose data solutions and tools.
• Perform data quality reviews and surveillance.
• Organize and integrate data using FAIR principles.
• Support analyses and understand data flow from collection to filing.
• Provide technical guidance to FSPs, CROs, and teams.

Skills

Leadership

Data analytics

Visualization tools

Programming languages

Data governance

Education

BS or MS in Life Sciences, Data/Computer Science, Bioinformatics

Tools

SAS

R

Python

SQL

Job description

Location: South San Francisco, CA (hybrid - 3 days onsite / 2 days WFH)

Pay: $55/hr-$85/hr

Please note that at this time we are unable to sponsor employment authorization (both new and transfer)

A leading Global Biotech Company is seeking a Clinical Data Manager II who will work within a team of experts in data life‑cycle management that acquire and curate data for use in exploratory research, clinical development and evidence generation. The Clinical Data Manager will collaborate with peers within the function and across the organization to identify, design and execute fit‑for‑purpose data management solutions. They will ensure the timely completion of data management deliverables and partner with Functional Service Providers (FSPs), DM CROs and other vendors, overseeing and providing technical expertise in the delivery of high‑quality data.

Responsibilities

• Project Management: Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies & projects, including the implementation and adoption of new technologies
• Stakeholder Management: Proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made. Inform stakeholders of key deliverables and act on changing milestones.
• Vendor Management: Partner with relevant functions for external data vendor selection and management. Oversee development of data transfer agreements with vendors ensuring use of standards, fit‑for‑purpose data models and transfer intervals
• Data Collection and Acquisition: Act as experts for data collection, advising teams and stakeholders on best practices and proposing innovative solutions. Ensure high quality data and compliance with applicable regulations and standards.
• Provide Data Solutions: Stay current with and adopt emergent data collection, data management, visualization and provision tools and applications to ensure fit‑for‑purpose and impactful approaches. Deliver on solutions as needed.
• Data Quality Review: Use data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in the data to ensure high quality results.
• Data Curation: Organization and integration of data collected from various sources. Maintain value of data through application of FAIR (Findable, Accessible, Interoperable, Reusable) principles.
• Support Analyses: Partner with stakeholders to understand their data insight needs and offer Data Management solutions. Demonstrate a strong understanding of the data flow from collection to analysis and filing (if applicable).
• Technical Consultant: Offer guidance and advice to peers within the function, to key stakeholders, and to FSPs, CRO and collaborative groups on technical solutions to ensure high quality data collection and delivery. Deliver on solutions as needed.

Qualifications

• BS or MS in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience.
• 5-10 years of relevant work experience.
• Knowledge of CDISC data standards, ICH-GCP and working in regulated environment
• Demonstrated leadership capabilities and decision-making, negotiation, motivation and influencing
• Experience with data analytics and/or visualization tools and techniques
• Knowledge of biological principles, display interest and demonstrate scientific curiosity including understanding of data types and their scientific use (clinical, biomarker, WGS, RNA-seq, etc.
• Familiarity with EDC systems Experience in leading the collection of clinical trial and/or Real World Data (preferred).
• Experience in enterprise level operating systems and familiarity with databases. Fluency in programming languages (SAS, R, Python, SQL, etc). Experience with tools related to technologies required to undertake analyses on large data sources with computationally intensive steps (SQL, parallelization, Hadoop, Spark, etc) (preferred).

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non‑discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.