Associate CDM Global Library Standard and Reporting Director

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:

Crinetics Pharmaceuticals is seeking a highly skilled and experienced Medidata Rave Global Library leader to support our Clinical Data Management team. This position will be responsible for the development, maintenance, and governance of Crinetics’ Medidata Rave Global Libraries, while also supporting study-specific EDC build activities.

             

A core focus of the role will be ensuring the consistent application of CDASH/CDISC data standards across all library assets, including Case Report Forms (CRFs), edit checks, and custom functions. The ideal candidate will hold Medidata Rave Study Builder Certifications, and with proven experience in building and maintaining global libraries to support oncology and endocrine studies, while ensuring compliance with regulatory and GxP standards.

The position will also support data visualization efforts, EDC-IRT integrations, EDC-eCOA integrations, and other system integrations if needed. Will also assist Crinetics Rave URL management.

The position will also be involved in the development of SOPs, 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:

• Design, development, and maintenance of Crinetics’ Medidata Rave Global Library, including CRFs, edit checks, derivations, and custom functions.

• Serve as the subject matter expert for Rave Custom Function development, including scripting, validation, deployment, and troubleshooting.

• Ensure all global library assets are aligned with CDASH/CDISC standards, ICH-GCP, 21 CFR Part 11, and internal SOPs.

• Support study teams in the deployment and reuse of standardized library components across trials, especially for oncology and endocrine therapeutic areas.

• Establish and maintain a formal governance process for the Rave Global Library, including oversight and documentation of any requests to update or modify standard elements.

• Lead the review, impact assessment, and approval process for proposed changes to global library content to maintain consistency and compliance.

• Work with vendors and internal stakeholders on EDC-IRT and EDC-eCOA integrations

• Work with Data Managers and CROs to develop EDC study databases

• Identify and implement opportunities for automation, process improvement, and efficiency gains within EDC and library management practices.

• Design, develop, and maintain interactive dashboards and reports using Power BI or other data visualization tools

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
• Minimum of  10-12 years of EDC study development experience, including at least 9 years of Medidata Rave Global Library experience.
• Proven experience in developing and maintaining Rave libraries in oncology and/or endocrine therapeutic areas.
• Hands-on expertise in building CRFs, edit checks, derivations, and complex custom functions using Rave Architect.
• Extensive experience working with CROs.
• Prior experience working on EDC-IRT integration, EDC-eCOA integration is preferred.
• Proficient in clinical data visualization with Power BI. Experience with Spotfire, Crystal Report, Tableau are very helpful.
• In-depth knowledge and experience with CDASH, SDTM, and regulatory requirements including 21 CFR Part 11 and GCP.
• Demonstrated organizational and interpersonal skills. 

Preferred:

• Competence in programming, such as SAS, Python, Power BI, Business Object, Tableau for data visualization is a big plus.
• Medidata Rave Custom Function Developer Certification and Medidata Rave Study Build Certification

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.

Vaccination requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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.

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Salary Range

The salary range for this position is: $162,000 - $203,000.

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.