Site Excellence Partner
The Site Excellence Partners are 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 Excellent Partners are accountable for identifying Monitor 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 risk prediction tools and plans (e.g., IQMP, the Site Quality Risk Dashboard) 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, Central Monitoring signals,
Dashboards 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
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 Monitor or alone
depending on the nature of the issue(s).
Work with CRO Monitors, and other Pfizer and CRO colleagues as appropriate, to drive resolution of
Accountable for identifying site and Monitor 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 with other country colleagues across study & assets in the portfolio to drive accelerated drug delivery.
May act as a Subject Matter Expert on Pfizer systems and processes Review of monitoring visit reports.
Support development and delivery of decentralized capabilities at investigator sites.
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.
Site and Study Management Interface:
Support local Investigator relationship management with the Site Relationship
Partner and Country Trials Manager if required.
Serve as point of contact for quality and safety escalations for CRO, Monitors, Site Relationship
Partner, Country Trials Manager and Study Team.
Support the resolution of operational obstacles at the site / country level in order to advance the
site and study deliverables.
The Site Excellence Partner may be required to support some or all of the primary responsibilities of the Site
Relationship Partner and Country Trials Manager, 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.
QUALIFICATIONS / SKILLS:
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 + 5 years of clinical research experience
English is essential. Proficiency in more than one language is preferred.
Solid knowledge of clinical development processes with strong emphasis on monitoring.
Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance.
Site Management/Monitoring (Monitor) experience.
Project management experience preferred in the clinical development area.
Ability to lead, troubleshoot and influence for delivery.
Eligible for Employee Referral Bonus: YES
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