Sr. Manager CDM SAS Programming and Reporting

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 Manager will support Clinical Data Management (CDM) in the systematic analysis, validation of the EDC data, laboratory and other data types from the external vendors.  Will contribute and improve the process for external data acquisition and validation.  Will support clinical data reviews, validations, and reconciliations. Will support metric reporting and data visualization. Will support EDC development.

The Senior Manager will also be involved in development of SOP(s), data standards and standardization, will contribute to the ongoing practices in DM processes with internal study lead data managers and/or vendors and driving for DM operation excellence.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Serves 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.
• Ensures 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.
• Provides 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.
• Implements the data validation and quality assurance solutions for systematic data management of the external vendor data.
• Contributes 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.
• Collaborates with cross functional peers to facilitate and optimize the process for data-driven business.
• Leverages data management and related expertise to promote best practices across the projects in drug development lifecycle and enhances collaboration with relevant stakeholders.
• Contributes to team building, standardization and process improvement to achieve the defined data quality with cost efficiency.
• Participates in regulatory audit and/or company initiatives.

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. Graduate degree is preferred but not required.
• At least 9 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:

• 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.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

Equal Opportunity Employer:

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 (including gender identity and/or expression), 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.

Total Compensation:

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.