Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

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, Clinical Data Management, will be responsible for all clinical data management activities and deliverables for the assigned study / studies 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 vendor service oversight, vendor invoice verification, budget contract negotiations and management, being the subject matter expert of data management to provide guidance and suggestions to vendor and the study team for all data management deliverables and timelines from study start-up through study close-out, final reporting, and data archiving.

The Senior Manager will be involved in development of SOP(s), data standards and standardization, managing and leading the ongoing practices in DM processes with internal study resources and / or vendors for the responsible study / studies and driving for DM operation excellence.

The Senior Manager will also partner with other functional groups and external vendors to ensure timelines and the quality of data deliverables of the responsible study / studies.

Essential Job Functions and Responsibilities

These may include but are not limited to :

• Manages the assigned study / studies and makes expert recommendations and / or decisions that assure timelines, deliverables and data quality.
• Collaborates cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process.
• Resolves and / or escalates issues encountered at the study level and ensures the performance of the data management function.
• Provides effective CRO / vendor oversight to ensure requirements are met and the project plans are executed to meet the development needs.
• Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders.
• Contributes to team building and best practice to achieve the defined data quality with cost efficiency.
• Participates in regulatory audit and / or company initiatives.

Education and Experience

Required :

Preferred :

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.

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.

Salary Range

The salary range for this position is : $138,000 - $172,000. 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.