Clinical Data Manager/Analyst - Genesis Corp./New Journey AI LLC

Our client, the world's leading search engine and technology company, is seeking a Clinical Data Manager/Analyst. This is a 6 month + contract and hybrid remote position located in South San Francisco, CA.

Summary:

• As a Clinical Data Manager/Analyst in the Quantitative Sciences organization, you will be responsible for supporting and managing the collection, capture, quality, and integrity of data, from diverse sources, including electronic health records, eCRF, ePRO, digital health technologies including apps and sensors, digital biomarkers, advanced specialty labs, images, and others.
• You will plan, monitor, and manage across data streams from data capture through ingestion into the client platforms, ensuring data collected are of high quality, documented, and ordered to support planned and potential analyses and uses.
• You should be fluent in the use of technical and statistical tools that enable assessment and review of data.
• As a member of the Clinical Data Management team you will work with cross-functional colleagues to integrate the team's work across client, and develop new models to enable efficient clinical data management activities at-scale to build our product offerings supporting sponsored clinical research and evidence generation with our external partners.

Responsibilities:

• Provide clinical data management support across a diverse portfolio of client studies and a diverse range of data streams, including clinical data, sensor data, advanced molecular data, app data, and imaging data.
• Develop innovative Data Management Plans (DMP), enhanced as required through the lifecycle of study projects to incorporate cross-data stream checks, and ensure DMP is followed according to study design and requirements. Develop Data Quality Plan, considering the full range of data sources, and perform specified validation and quality management activities.
• Build and develop databases (DB) to protocol objectives and specifications, inclusive of electronic Case Report Form (eCRF) and electronic patient reported outcome (ePRO) design and annotation, edit rules/checks, query logic and data validations.
• As required, coordinate and communicate with internal partners and external vendors.
• Complete validation of database build, including but not limited to: developing test scripts, execution logs for validation, edit checks, data listings, data reconciliation and/or coding and validation summary report.
• Collaborate with cross-functional teams to monitor and provide data to support clinical operational activities and reports.
• Partner with Quantitative Sciences to develop and document data repository schema across data sources.

Requirements:

• Bachelor's degree in health or science, or equivalent practical experience.
• Advanced degree in informatics, clinical research, or computer science preferred.
• 7+ years of data management and/or related work experience in a pharmaceutical, biotech, or medical device industry/company.
• Experience with Good Clinical Practices (GCP), Good Pharmacoepidemiology Practice (GPP), clinical research and medical product development, clinical trial processes and related regulatory requirements and terminology (e.g., 21 CFR Part 11, human subjects research).
• Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.

Desired

Pay rate range: $57.01 - $89.06 hourly

If you have the described qualifications and are interested in this exciting opportunity, please apply!

Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:

• Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
• The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
• Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
• Behavioral Health Platform
• Medical, Dental, Vision
• Voluntary Hospital Indemnity (Critical Illness & Accident)
• Voluntary Term Life Insurance
• 401K
• Sick Pay (for applicable states/municipalities)
• Commuter Benefits (Dallas, NYC, SF)
• Remote opportunities available

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.