Clinical Operations Lead III--Cambridge, MA

Location: Cambridge, Massachusetts, USA
Salary: US$90 - US$112 per hour + negotiable
Job Type: Permanent
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Clinical Operations Lead III

Responsibilities

  1. Partners with Medical Research and other functions to:
  • Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, and feasible protocols and robust data monitoring plans * Leverage appropriate on going data review to identify and mitigate patient, study design, data or study conduct issues * Ensure all operational aspects support end point integrity and data validity.
  1. Secures operational excellence and delivery for one or more clinical studies by:
  • Developing operational strategy (including ancillary vendors) aligned with the program strategy and incorporating country input through the study Clinical Country Lead * Overseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO * Driving performance, quality, timelines and relationships through the CRO partnership model * Chairs the [Study Management Team] in partnership with the CRO study Lead of the [Study Management Team]; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
  • Partnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the relevant vendor management member for issue resolution
  1. Strives for effective, consistent, efficient and compliant processes by:
  • Championing best practice development in Phase planning and seeks opportunities for innovation and efficiency with the Clinical Operation Management group * Seeks interdependencies and synergies with other trials and programs to enhance superb planning and execution across all studies in a phase * Follows established procedures and SOPs; seeks ways to improve and streamline processes to support the GCO CRO outsourcing model * Embodies a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the new CRO partnership model.

Qualifications:

  • 4-5 years of Clinical Trial Management experience
  • Prior CRO or investigator site and/or monitoring experience is a plus
  • Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV)
  • A working understanding of cross functional drug development
  • Ability to establish operational plans and support the CRO in the execution of the plans
  • Requires a balance of scientific and operational/project management and team leadership expertise
  • Excellent project management skills, including risk assessment and contingency planning
  • Must have effective prior CRO management skills and be able to adapt to the GCO outsourcing model.

If you or someone you know is interested in this position, please submit a resume to Isabella Martin i.martin (at sign)realstaffing.com.

Thanks!

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