Position Summary

The Clinical Operations Quality Lead is responsible for assessing Clinical Operations performance with a focus on quality through the objective review and assessment of tasks related to inspection readiness of Odonate’s clinical studies including study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring and site close-out activities. This individual will perform both on-site and off-site reviews of study activities as defined in the Clinical Operations Quality Oversight Plan. The COQL will liaise and provide feedback to the Clinical Operations, Clinical Project Management and Clinical Training teams on performance areas. The COQL may also serve as back-up support for other Clinical Operations tasks.

Essential Duties and Responsibilities

  • Assess Clinical Operations’ performance of various tasks with a focus on quality and compliance to principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines through the review and confirmation of processes and data including various report reviews, source data verification, Investigator Study File/Trial Master File review, review of protocol deviation, safety reporting management and other clinical monitoring activities
  • Proactively coordinate the necessary activities required to review and assess Clinical Operations tasks related to study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring, site close-out activities and inspection readiness of Odonate’s clinical studies, including liaising with various functional groups for systems access, report definition, and coordinating site visits
  • Provide objective assessments and summary of performance assessments to Site Directors, Regional Directors, VPs of Clinical Operations, Chief Development Officer and other management team members, in a timely manner and as required
  • Discuss and collaborate with the Clinical Operations, Clinical Project Management and Clinical Training teams on performance areas that need clarification and/or additional training
  • Provide back-up support for certain Clinical Operations tasks, including study start-up or monitoring tasks
  • Contribute to overall Clinical Operations team knowledge by sharing best practices and participating in improvement initiatives
  • Contribute to the review of Odonate’s systems and procedures, as needed

Qualifications

  • Bachelor’s Degree in a Life Sciences discipline required
  • Bachelor’s Degree in Nursing or RN a plus
  • Minimum 5 years of clinical trial work experience with a bio-pharmaceutical company or CRO required
  • Minimum 1 year of work experience in the oncology therapeutic area is required
  • Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall global drug development required
  • Experience and proven proficient in CTMS and eTMF systems preferred
  • Thorough understanding of FDA, EMA, ICH and GCP guidelines and applicable local regulations
  • Strong ability and enthusiasm to interpret study level metrics data and proactively identify and mitigate risks
  • Demonstrated critical thinking with ability to learn complex subjects and apply knowledge across various activities
  • Detail-oriented, organized and committed to quality and consistency
  • Results driven and capable of managing competing high-priority assignments
  • Proven track record of achieving deliverables within specified timelines
  • Excellent team-interaction skills and ability to work successfully in team settings
  • Ability to work in a dynamic environment with a high degree of flexibility
  • Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs
  • Excellent written and verbal communication skills in English, as well as in applicable local language
  • Must be willing and able to travel domestically and/or internationally up to 60-80%

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