Senior Manager Clinical Operations

2 weeks ago

Redmond, United States Theery Full time

Duties And Responsibilities:

  • Develop, maintain, and manage high-quality detailed study timelines; interface regularly with study team and internal cross-functional stakeholders to ensure key activities are well-coordinated, are accurately reflected on the study- and program timelines and align with corporate and program goals.
  • Prospectively identify timeline risks, proactively communicate risks to management, internal stakeholders, and CRO teams, and coordinate development and implementation of risk mitigation strategies to facilitate efficient, on-time execution of studies.
  • Collaborate with other functional groups within the company where necessary to support milestone achievement.
  • Manage routine status reporting including study timeline and budget dashboards and management updates.
  • Provide monthly milestone and timeline updates to Portfolio Management for entry into corporate project management system.
  • Develop, maintain, and manage high-quality detailed study timelines; interface regularly with study team and internal cross-functional stakeholders to ensure key activities are well-coordinated, are accurately reflected on the study- and program timelines and align with corporate and program goals.
  • Prospectively identify timeline risks, proactively communicate risks to management, internal stakeholders, and CRO teams, and coordinate development and implementation of risk mitigation strategies to facilitate efficient, on-time execution of studies.
  • Coordinate development and review of IP labels, working closely with relevant functional areas to produce a final mockup label meeting clinical and regulatory requirement.
  • Develop and contribute to appropriate study plans (e.g., monitoring, pharmacy, data management, laboratory, manual of procedures, communication, etc.).
  • Oversee protocol implementation by reviewing progress reports from CROs, monitoring, and data quality reports, and audit reports as needed.
  • Support procurement, import, and delivery of clinical trial supplies (including Investigational Product) according to trial protocol specifications.
  • Oversee clinical trial registry postings.
  • Provide input into the selection and qualification of clinical trial sites and CROs
  • Provide input into the contractual activities of clinical sites and CROs, including outlining partner roles and responsibilities and technical milestones triggering payments.
  • May work on 1-3 clinical studies depending on complexity and design


Education and Experience:

  • Bachelor’s in related discipline required; a combination of relevant education and applicable job experience may be considered.
  • 7 years of related experience in a CRO, Biotech or Pharmaceutical organization
  • Solid understanding of drug development and clinical operations.
  • Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
  • Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint and Outlook.
  • Must be a self-starter who works with minimal supervision.
  • Works effectively in a matrix cross-functional environment.
  • Good business judgment and a strong understanding of the unique aspects of clinical financials.
  • Excellent communication skills, (verbal and written) including the ability to understand and present budget information effectively.
  • Works with high sense of accountability/urgency
  • Expertise in GCP, ICH, and other Guidance documents and policies related to clinical trial operations.

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