Clinical System Management, Senior Manager

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 (Data System), Clinical Data Management, will be responsible for clinical data system management and maintenance activities for the assigned data system(s) in accordance with ICH/Good Clinical Practices (GCP), GDCMP and other relevant regulations, procedures and guidelines. The responsibilities of this position include but are not limited to data system setup, system configuration and system maintenance, vendor service oversight and validation, being the subject matter of expert of clinical data system(s) to provide suggestions and solutions to data system related needs and supports and to ensure data management deliverables and timelines of all studies from study build through study database lock and data archiving.

The Senior Manager (Data System) will be involved in development of SOP(s), data standards and standardization, contributing 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:

• Manages the responsible data system(s) and ensure the system functions, including EDC, Reporter, Coder, Lab Module, etc.
• Collaborates cross-functionally and/or with the system provider to resolve system related issues and ensure trial continuity throughout the drug development life cycle.
• Perform system setup, configuration and maintenance and provide guidance on system integration, such as IRT-EDC integration, eCOA-EDC integrations to ensure requirements are met and the project plans are executed to meet the business needs.
• Provides guidance on EDC database design for studies using Medidata Rave
• Manages the Medidata Rave system users, sites, studies, reports, sFTP, as well as the MedDRA and WHODD Coding Dictionaries
• Leverages data management and related expertise to promote best practices across the projects in drug development lifecycle and enhances collaboration with relevant stakeholders for best practice.
• 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.
  
  

Required

Education and Experience:

• MS/BS in Information Technology (IT) or related field
• 7 + years of direct data system management experiences and at least 5 years working experiences on Medidata Rave data capture, global library development, data reporting and system management in the Biotech, Pharmaceutical or CRO industry
• In depth knowledge of clinical data systems in system requirements, system setup, configuration compliance, data capture, validation and data reporting.
• Experiences in Medidata Rave system setup, configuration, Global Library, EDC database building and management are must
• 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
• Experiences with clinical data lifecycle from database set-up and maintenance to database lock and archiving
  
  

Preferred

• Knowledge in current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IRT).
• Competence in programming, such as 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.

The Anticipated Base Salary Range: $150,000-$170,000

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.

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.

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.