Director, Clinical Data Management (EDS)

Categories: Biometrics
Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. 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. Come join our team as we transform the lives of others.
As the subject matter expert for the handling and management of laboratory and other external data types, the Director, Clinical Data Management will serve as the Head of the External Data Solutions (EDS) team and oversee all data management activities associated with the management and transfer of data from external vendors. 
These may include but are not limited to:
  • Act as representative of the inter-department subject matter expert for EDS for all trials to enable planning, coordination, and timely delivery of complete, high quality, and reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance
  • Serve as a key contributor to evaluate, implement, and lead process and infrastructure development/improvement. This may include external vendor management and development, system evaluations and selections, external data integrations, and adhering to end-to-end data standards
  • Ensure 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
  • Assist with implementing the corporate strategic plan within the department – planning and managing internal and external EDS resources, and assisting with managing the department budget
  • Provide strategic, organizational, and operational management and guidance to the personnel and teams within EDS.
  • Provide technical and functional oversight of the day-to-day work and work products of EDS clinical data management staff, as needed, including clinical data collection, processing, quality control procedures, timelines, and documentation
  • Assist with the selection and management of data management vendors; identify potential risks, resolve issues with CROs; oversee vendor management plans and review quality metrics; provide guidance, and monitor the progress of DM activities with CROs or other vendors
  • Contribute 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
  • Collaborate with cross functional peers to facilitate and optimize the product development and registration process
  • Other duties as assigned
  • Bachelor’s degree in life sciences, computer, statistics, etc. or equivalent combination of a bachelor’s degree and relevant job experience. Graduate degree is preferred but not required
  • At least 12 years of relevant data management experience, including at least 5 years leading the management of external data, and at least 8 years of managerial experience leading CDM teams in the biotech, pharmaceutical, medical device or CRO industry, including experience in multiple therapeutic areas and in various phases of drug development.
  • Experience leading CDM infrastructure setup & deployment and CDM process improvement
  • Experience on CRO selection and oversight as well as management
  • Knowledge of the current industry best practices, FDA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations
Experience in clinical trial data collection systems (EDC, eCOA, CTMS, Drug Safety Database Systems, IVRS/IXRS, reporting tools, data visualization, etc.) and practical knowledge of data integration between data collection systems.
Detailed knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment
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. 


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