Crinetics Pharmaceuticals

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

Associate Manager, Centralized Monitoring

Full TimeRemoteTeam 201-500Since 2015H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

5 days ago

Salary

$115K - $144K / year

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

• Execute and oversee centralized monitoring activities across clinical trials using a risk-based quality management (RBQM) framework • Perform ongoing centralized monitoring reviews using clinical, operational, and quality data sources • Identify emerging study-level and site-level risks through Key Risk Indicators (KRIs) • Support the evaluation of trends, data anomalies, and protocol deviations • Document and report signals, findings, and recommendations within designated systems • Collaborate with Clinical Monitoring to support alignment of monitoring approaches with ICH-GCP E6 (R2/R3) and internal SOPs • Support oversight of centralized monitoring vendors, tools, or platforms • Participate in ongoing improvements in standardizing technologies, systems, processes, and training materials

Job Requirements

  • Bachelor’s degree in life sciences, health sciences, or related disciplines
  • 5 years of clinical research experience
  • Centralized monitoring, RBQM, or clinical data review experience
  • Strong understanding of clinical trial processes
  • Solid understanding and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements.
  • Highly advanced knowledge of ICH-GCP E6 (R2/R3) and risk-based requirements.
  • Experience with clinical trial systems such as EDC, eTMF, IRT, and CTMS.
  • Strong interpersonal skills with advanced oral/written communication and presentation skills.
  • Proficiency in Microsoft Office tools.

Benefits

  • Health insurance plans for employees (and their families) including medical, dental, vision and basic life insurance
  • 401k match
  • 20 days of PTO
  • 10 paid holidays
  • Winter company shutdown
  • Discretionary annual target bonus
  • Stock options

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