[Hiring] Senior Manager, Clinical Data Management @Crinetics Pharmaceuticals, Inc.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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. • Vendor service oversight • Vendor invoice verification • Budget contract negotiations and management • 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 • Development of SOP(s), data standards and standardization • Managing and leading ongoing practices in DM processes with internal study resources and/or vendors • Partner with other functional groups and external vendors to ensure timelines and quality of data deliverables Qualifications • MS/BS in life sciences or related field • 7+ years of direct data management experience • At least 3 years of CRO oversight experience • In-depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry • Strong project management skills and experience working with CROs/vendors • Demonstrated organizational and interpersonal skills • Detail-oriented with excellent communication skills • Extensive experience working in cross-functional settings • Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance • Knowledge of GCP, ICH and other regional regulations and compliance • Experience with clinical data lifecycle from database set-up and maintenance to database lock and archiving • Working knowledge of current technologies in clinical trial data collection systems Requirements • Knowledge in current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IRT) • Competence in Excel and/or SAS programming is a big plus Benefits • Discretionary annual target bonus • Stock options • ESPP • 401k match • Top-notch health insurance plans for employees (and their families) including medical, dental, vision, and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown Physical Demands and Work Environment • 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 • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities 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: $149,000 - $185,000. Apply tot his job