Site Excellence Partner

작업 내용

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 Excellence 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 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 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 oversight issues.
• 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.
  

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.
  

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

Education

• 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 + 7 years of clinical research experience and/or quality management
  

Experience

• English is essential. Proficiency in more than one language is preferred.
  

Experience

• 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.
• Ability to work Independently.
  

Technical Competencies

• Demonstrated knowledge of clinical research processes and global and local regulatory requirements; ability to gain command of process details.
• Demonstrated ability to work in cross-functional matrix environment.
• Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
• Superior technical skills; ability to evaluate, interpret and utilize multiple and varied databases (e.g., CTMS, CAL) and systems to proactively manage deliverables and tasks
  

Behavioral Competencies

• Considers stakeholders including regulatory agencies and marketing when developing strategies and future directions.
• Utilizes and encourages innovative approaches to build and maintain a competitive advantage. Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration.
• Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards.
• Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures.
  

LKN:

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

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