Senior Clinical Oversight Manager

Kailera

Waltham, MA, USA
$143,000—$175,000 usd; not specified; comprehensiv...
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Clinical monitoring oversight visit process
Ich gcp and applicable regulations
Clinical oversight sops and templates
** Kailera is seeking a Senior Clinical Oversight Manager to oversee clinical trial compliance and execution, ensuring adherence to regulations and quality standards. The role requires significant clinical trial experience and offers competitive benefits alongside a commitment to an inclusive workplace culture. **

Job Summary

  • The Senior Clinical Oversight Manager is responsible for executing the Clinical Monitoring Oversight visit process and Clinical Oversight Metrics, representing Kailera during these visits and overseeing study execution.
  • Responsibilities include developing the Clinical Monitoring Oversight strategy, evaluating Service Provider activities, assigning oversight visits, and ensuring data integrity and site readiness for inspections.
  • The company offers comprehensive health coverage, flexible time off, paid holidays, a year-end shutdown, a wellness stipend, 401(k) match, tuition reimbursement, commuter benefits, and annual bonus opportunities and equity grants.

Matching Summary

Match Score: 75

** Kailera is seeking a Senior Clinical Oversight Manager to oversee clinical trial compliance and execution, ensuring adherence to regulations and quality standards. The role requires significant clinical trial experience and offers competitive benefits alongside a commitment to an inclusive workplace culture. **

Salary

$143,000—$175,000 USD; Not specified; Comprehensive health coverage, flexible time off, paid holidays, year-end shutdown, wellness stipend, 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, annual bonus opportunities, equity grants

Skills & Requirements

Must-have

  • Clinical Monitoring Oversight visit process
  • ICH GCP and applicable regulations
  • Clinical Oversight SOPs and templates
  • Vendor oversight activities
  • KPI tracking and issue management
  • Global Oversight CRA management

Nice-to-have

  • Entrepreneurial spirit
  • Team-oriented culture
  • Collaboration and integrity
  • Diverse backgrounds and perspectives

Key Requirements

  • 8+ years clinical trial experience
  • Phase I-III clinical trials experience
  • Risk-based monitoring experience
  • CRA Management experience
  • Vendor oversight experience
  • Bachelor's degree in scientific or healthcare field

Work Rights

Not specified

Tailored Resume

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