Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

POSITION SUMMARY:

The Senior Data Reporting and Data Visualization Manager will be responsible for the systematic analysis, validation of the EDC data, laboratory and other data types from the external vendors. This candidate will contribute and improve the process for external data acquisition, validation, and will support clinical data reviews, validations, and reconciliations. The candidate will support metric reporting, data visualization, and EDC development and will also be involved in the development of SOP(s), data standards and standardization, will contribute to the ongoing practices in Data Management (DM) processes with internal study lead data managers and/or vendors and driving for DM operation excellence.

EDUCATION AND EXPERIENCE:

Required:

• Bachelor’s degree in life sciences, computer science, statistics, or equivalent combination of a bachelor’s degree and relevant job experience.
• 12+ years of programming, especially SAS programming, and relevant data management experience, including management of external data, implementing systematic data acquisition, validation and reporting in the biotech, pharmaceutical, medical device or CRO industry.
• Solid experience with Medidata Rave and Veeva Clinical Trial Management are required.
• Highly skilled in data listings, and ad-hoc reporting.
• Proficient in clinical data visualization with Power BI. Experience with Spotfire, Crystal Report, Tableau are very helpful.
• Experience in CDM infrastructure setup & deployment, system integration and CDM process improvement. Experiences in eCOA, IRT/EDC integration are highly valued.
• Experience in external data validation process and automation is a big plus
• Experience in CRO management.
• Knowledge of the current industry best practices, FDA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations.
• Strong project management skills and experience working with stake holders and CROs/vendors
• Demonstrated organizational and interpersonal skills.
• Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting.
• Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance
• Knowledge of GCP, ICH and other regional regulations and compliance

Preferred:

• Graduate degree in sciences or business
• Knowledge in current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IRT).
• Competence in programming, such as SAS, Python, PowerBI, Business Object, Tableau for data visualization is a big plus.

These may include but are not limited to:

• Serve as a key contributor to evaluate, implement, and lead the process and infrastructure development/improvement in the scope of data reporting, external vendor data management, data acquisition and data validation. This may include system evaluations and selections, external data integrations, and adhering to end-to-end data standards.
• Ensure all external data comply with Data Transfer Specifications (DTS), standards, protocols, SOPs and overall clinical objectives. Help ensure the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards.
• Provide technical support and functional oversight of the day-to-day work and data reporting in clinical data management, including clinical data collection, processing, quality control procedures, timelines, and documentation.
• Implement the data validation and quality assurance solutions for systematic data management of the external vendor data.
• Contribute to identifying, locating, evaluating, and validating CDM documents, data transfer processes and infrastructure, and databases required for report generation or regulatory submission.
• Assist with the coordination of non-routine projects, as applicable, in support of development initiatives.
• Collaborate with cross functional peers to facilitate and optimize the process for data-driven business.
• Leverage data management and related expertise to promote best practices across the projects in drug development lifecycle and enhance collaboration with relevant stakeholders.
• Contribute to team building, standardization and process improvement to achieve the defined data quality with cost efficiency.
• Participate in regulatory audit and/or company initiatives.