Site Excellence Partner
Pfizer
Tamsui, Taiwan
2天前

The Site Excellence Partner is accountable for safeguarding the quality and patient safety at the investigator site and are responsible for site and monitoring oversight.

The Site Excellence Partner is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.

The Site Excellence Partner is accountable for identifying CRA performance issues and are responsible for ensuring appropriate corrective and preventative actions are put in place.

Responsible for process, standards, and oversight :

  • Responsible for site and monitoring quality, regulatory and GCP compliance.
  • Drive inspection readiness and provide support for site audits / inspections as needed, following through audit / inspection finding to resolution.
  • Follow the study oversight plan and proactively put in place mitigations for known / anticipated risks.
  • Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks.
  • Lead risk assessment at the site / country level for their studies, including identifications of mitigation and control.

  • Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.
  • Demonstrate use of data to enhance quality and accelerate study delivery.

  • Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control.
  • Conduct and report oversight activities, both remote and onsite visits, according to Pfizer requirements and standards.
  • Perform additional oversight visits / reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs.
  • These may be conducted with the assigned CRA or alone depending on the nature of the issue(s).

  • Work with CRO CRAs and other CRO colleagues as appropriate, to drive resolution of oversight issues.
  • Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and / or site level, escalating, and supporting implementation of CAPAs to address these.
  • Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery.
  • Identify potential improvements for Pfizer processes.
  • Review of monitoring visit reports.
  • Serve as key contributor to process improvement initiatives and may lead local area initiatives.
  • Support in external environment shaping activities for a country.
  • Act as a Subject Matter Expert for a category or global processes within the GSSO organization.
  • Support onboarding of new colleagues in country.
  • Protocol Site Oversight

  • Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.
  • Attend Investigator meeting / protocol training to ensure clear understanding of the protocol requirements.
  • Seek assignment to complex protocols driven by demonstrated capability in role.
  • Site and Study Management Interface

  • Support local Investigator relationship management with the Site Relationship Partner.
  • Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team.
  • Support the resolution of operational obstacles at the site / country level in order to advance the site and study deliverables.
  • Support vendor relationship management at country-level.
  • The Site Excellence Partner may be required to support some or all of the primary responsibilities of the Site Relationship Partner, as example, proactively collaborating and providing local intelligence to country outreach surveys, targeted sites strategies, study design, and Pfizer pipeline opportunities.

    The Site Excellence Partner may be required to support additional primary responsibilities of the Site Relationship Partner in study start up, activation, and execution to the plan for targeted sites, helping coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Pfizer communications and enhancing overall visibility into and confidence of quality of site-level activities.

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

    Medical

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