Crinetics Pharmaceuticals

Discovering drugs for endocrine diseases and endocrine-related tumors. #acromegaly #crinetics #CarcinoidSyndrome

Senior Medical Affairs Operations Manager

OperationsOperationsFull TimeRemoteTeam 201-500Since 2015H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

4 days ago

Salary

$147K - $184K / year

Bachelor Degree8 yrs expEnglish

Job Description

• Managing the execution of medical affairs operations, investigator initiated clinical studies, post-marketing clinical studies and post-trial access programs • Overseeing the review, monitoring, and adherence to clinical protocols • Providing oversight of clinical affairs programs across all functional areas of the drug development process • Developing the subject recruitment/retention strategy and related initiatives • Overseeing TMF set-up, ongoing quality review, and final reconciliation of study documents • Developing training materials for the program team, investigational sites, and vendors • Collaborating with counsel to negotiate and draft contracts and agreements with CROs/vendors and clinical sites

Job Requirements

  • Bachelor’s degree required, preferably in a scientific discipline
  • Minimum of 8 years of prior clinical operations experience managing clinical trials
  • at least 5 years in a supervisory role
  • Experience managing clinical studies is preferred
  • Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, and IRT and EDC systems
  • Excellent understanding of the drug development process
  • Strong ability to analyze and generate reports
  • Understanding of FDA regulatory requirements (i.e. GCPs, CFRs, etc.)
  • Experience in rare disease and/or oncology is preferred

Benefits

  • Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
  • 20 days of PTO
  • 10 paid holidays
  • winter company shutdown
  • discretionary annual target bonus
  • stock options
  • ESPP
  • 401k match

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