Crinetics Pharmaceuticals, Inc. is looking for a Sr. Manager CDM SAS Programming and Reporting to support Clinical Data Management by analyzing and validating clinical data from EDC systems and external vendors. You will play a key role in improving processes for data acquisition, quality assurance, and visualization to advance our patient-centric drug development programs.
What You'll Do
- Serve as a key contributor to evaluate, implement, and lead process and infrastructure development for data reporting, vendor data management, acquisition, and validation.
- Ensure all external data comply with Data Transfer Specifications, standards, protocols, SOPs, and clinical objectives.
- Provide technical support and functional oversight of day-to-day work and data reporting in clinical data management.
- Implement data validation and quality assurance solutions for systematic management of external vendor data.
- Contribute to identifying, locating, evaluating, and validating CDM documents, data transfer processes, and databases for report generation or regulatory submission.
- Assist with the coordination of non-routine projects in support of development initiatives.
- Collaborate with cross-functional peers to facilitate and optimize data-driven processes.
- Leverage data management expertise to promote best practices across the drug development lifecycle.
- Contribute to team building, standardization, and process improvement to achieve defined data quality with cost efficiency.
- Participate in regulatory audits and company initiatives.
What We're Looking For
- Bachelor’s degree in life sciences, computer science, statistics, or equivalent combination of degree and relevant job experience.
- At least 9 years of programming, especially SAS programming, and relevant data management experience in biotech, pharmaceutical, medical device, or CRO industry.
- Solid experience with Medidata Rave and Veeva Clinical Trial Management.
- Highly skilled in data listings and ad-hoc reporting.
- Proficient in clinical data visualization with Power BI.
- Experience in CDM infrastructure setup & deployment, system integration, and CDM process improvement.
- Experience in CRO management.
- Knowledge of 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 stakeholders and CROs/vendors.
- Demonstrated organizational and interpersonal skills.
- Detail oriented with excellent communication skills and extensive experience working in cross-functional settings.
- Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance.
- Knowledge of GCP, ICH and other regional regulations and compliance.
Nice to Have
- Graduate degree.
- Experience with Spotfire, Crystal Report, Tableau.
- Experiences in eCOA, IRT/EDC integration.
- Experience in external data validation process and automation.
- 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.
Technical Stack
- SAS
- Medidata Rave
- Veeva Clinical Trial Management
- Power BI
- Spotfire
- Crystal Report
- Tableau
- Python
- Business Object
Team & Environment
You will support the Clinical Data Management (CDM) function, working in a patient-centric, inclusive, and science-driven team environment.
Benefits & Compensation
- Compensation: $148,000 - $185,000 + equity via stock options
- Discretionary annual target bonus
- Stock options
- ESPP
- 401k match
- Top-notch health insurance plans (medical, dental, vision, basic life)
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
Work Mode
This is an onsite position located in San Diego, California.
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
