Crinetics Pharmaceuticals

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

Senior Clinical Trial Manager

Clinical ResearchClinical ResearchFull TimeRemoteTeam 201-500Since 2015H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

31 days ago

Salary

$142K - $177K / year

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

• Managing the execution of clinical studies and data collection • Overseeing the review, monitoring, and adherence to clinical protocols • Interacting internally and externally with members of the cross-functional study team • Supervising more junior CTMs and Associate CTMs as required • Providing oversight of clinical research studies across all functional areas of the drug development process • Providing operational and strategic input into study planning and specific documents • Coordinating and leading study team meetings • Developing the subject recruitment/retention strategy • Overseeing TMF set-up, quality review, and reconciliation of study documents • Developing training materials for the study team • Managing information proactively and sharing with key stakeholders • Assuring compliance with ICH/GCP and other regulations • Overseeing preparation of RFPs and bid templates • Collaborating with counsel to negotiate and draft research contracts • Performing study risk management and implement mitigations • Managing and coaching direct reports

Job Requirements

  • Bachelor’s degree required, preferably in a scientific discipline
  • Minimum of 8 years of prior clinical operations experience managing clinical trials, preferably with CRO/small biotech experience; at least 5 years in a supervisory role
  • Experience managing early phase studies is preferred
  • Computer skills should include proficiency with Microsoft Office suite of software, electronic TMF systems, IRT and EDC systems
  • Excellent understanding of the drug development process
  • Effective verbal and written communication skills
  • Experience in rare disease and/or oncology is preferred

Benefits

  • discretionary annual target bonus
  • stock options
  • ESPP
  • 401k match
  • 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
  • winter company shutdown

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