Compliance Oversight Lead

Pfizer O firmie

  • mazowieckie

  • Ogłoszenie wygasło 4 lat temu
  • Specjalista
Compliance Oversight Lead

Responsible for oversight of site and monitoring study execution for assigned studies:

  • Ensure overall quality and regulatory and GCP compliance
  • Conduct and report protocol specific quality review visits according to Pfizer standards
  • Proactively identify, manage and escalate site issues and act as BU/Site interface as needed
  • Ensure resolution of site issues in order to maintain sound investigator relations
  • Maintain a thorough knowledge of protocol
  • Demonstrate TA expertise where appropriate
Responsibilities:
  • Perform protocol specific quality review visits.
  • Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
  • Perform additional site visits based on the type of issues that arise during the course of a study. These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).
  • Supports local Investigator relationship management
  • COLs to be included at an appropriately early stage of issue escalation, to ensure full awareness of emerging issues/challenges in country.
  • Support Audit/inspection for assigned project when appropriate and follow through audit/inspection finding resolution.
  • Attendance as an ad hoc member at Global Study Team meetings.
  • Responsible for communicating study level information to other COLs working on the protocol.
  • Review output from all PSQRVs on the study to identify trends and areas for improvement.
  • Review PSQRV metrics and work with study assigned COLs to ensure the minimum requirements for a study are being met in accordance with the PSQRV Plan.

Qualifications:
  • A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience:
  • BS/BSc/MS/MSc or equivalent + 4 years of clinical research experience
  • Ph.D./MD or equivalent + 2 years of clinical research experience
  • Skills in more than language are an advantage in this role
  • Solid knowledge of clinical development processes with strong emphasis on monitoring
  • Demonstrated ability to oversee a 3rd party (preferred)
  • Site Management/Monitoring (CRA) experience
  • Project management experience preferred in the clinical development area
  • Ability to lead, troubleshoot and influence for delivery
  • Independent approach

To apply please visit www.pfizercareers.com and search for JobID: 1019356
Compliance Oversight Lead

Responsible for oversight of site and monitoring study execution for assigned studies:

  • Ensure overall quality and regulatory and GCP compliance
  • Conduct and report protocol specific quality review visits according to Pfizer standards
  • Proactively identify, manage and escalate site issues and act as BU/Site interface as needed
  • Ensure resolution of site issues in order to maintain sound investigator relations
  • Maintain a thorough knowledge of protocol
  • Demonstrate TA expertise where appropriate
Responsibilities:
  • Perform protocol specific quality review visits.
  • Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
  • Perform additional site visits based on the type of issues that arise during the course of a study. These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).
  • Supports local Investigator relationship management
  • COLs to be included at an appropriately early stage of issue escalation, to ensure full awareness of emerging issues/challenges in country.
  • Support Audit/inspection for assigned project when appropriate and follow through audit/inspection finding resolution.
  • Attendance as an ad hoc member at Global Study Team meetings.
  • Responsible for communicating study level information to other COLs working on the protocol.
  • Review output from all PSQRVs on the study to identify trends and areas for improvement.
  • Review PSQRV metrics and work with study assigned COLs to ensure the minimum requirements for a study are being met in accordance with the PSQRV Plan.

Qualifications:
  • A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/experience:
  • BS/BSc/MS/MSc or equivalent + 4 years of clinical research experience
  • Ph.D./MD or equivalent + 2 years of clinical research experience
  • Skills in more than language are an advantage in this role
  • Solid knowledge of clinical development processes with strong emphasis on monitoring
  • Demonstrated ability to oversee a 3rd party (preferred)
  • Site Management/Monitoring (CRA) experience
  • Project management experience preferred in the clinical development area
  • Ability to lead, troubleshoot and influence for delivery
  • Independent approach

To apply please visit www.pfizercareers.com and search for JobID: 1019356

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