19 days old

Site Excellence Partner

Pfizer
Mexico, MO 65265
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**ROLE SUMMARY**



TheSite Excellence Partnersareaccountable for safeguardingthe qualityand patient safety at the investigator site and areresponsible forsiteandmonitoring oversight. The SiteExcellence Partneris responsible for utilizing andinterpretingdata from analytic tools, in conjunction with country and regional intelligenceto proactively identify risks to quality and compliance and todevelopand implement mitigation plans to address theserisks.TheSiteExcellent Partnersare accountable foridentifyingMonitor performance issues andare responsible for ensuringappropriatecorrective and preventative actions are put inplace.



**ROLE RESPONSIBILITIES**



**Responsible forprocess, standards, and oversight:**



+ Responsible forsite and monitoring quality, regulatory and GCP compliance.

+ Driveinspection readiness and provide support for site audits/inspections as needed, followingthrough audit/inspection finding to resolution.

+ Follow therisk prediction tools and plans(e.g.,IQMP, theSite Quality RiskDashboard)andproactively put in placemitigationsfor known/anticipated risks.

+ Responsible forsite and monitoring quality usingand interpretingsignals identified bySignal Interpretation Leadsin conjunction with local country intelligencetoproactively identify risks.Leadrisk assessment at the site/country level for their studies,including identifications of mitigation and control.

+ Maintainknowledge ofappropriate tools and resources (e.g.,metrics, site health, Central Monitoring signals, Dashboards etc.).Demonstrateuseofdata to enhance quality and accelerate study delivery.

+ Apply knowledge of data and analytics to targetsiteandstudy,recommendandimplementactions for mitigation and control.

+ Conduct and report oversight activities, bothremoteand onsite visits,according to Pfizer requirements and standards.

+ Perform additional oversight visits/reviews based on the type of issues that ariseduring the course ofa study, and the analytics andvisualizationsoutputs. These may be conducted with the assigned Monitor or alone depending on the nature of the issue(s).

+ Work with CRO Monitors,and otherPfizer andCRO colleagues as appropriate, to drive resolution of oversight issues.

+ Accountable for identifying site andMonitor performance issues andquality events and other quality issues at patient and/or site level,escalating,and supportingimplementation of CAPAsto address these.

+ Demonstrates the learning culture by ensuringsite quality and trends,includingpreventive actions are sharedwith other country colleaguesacrossstudy &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 deliveryofdecentralized 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 ensureclearunderstanding of the protocol requirements.



**Siteand StudyManagement Interface**



+ Supportlocal Investigator relationship managementwith theSite Relationship PartnerandCountryTrialsManagerif required.

+ Serve as point of contact for qualityand safety escalations for CRO, Monitors, SiteRelationship Partner,CountryTrialsManagerand StudyTeam.

+ Supportthe resolution of operational obstacles at the site / country level in order to advance the siteandstudydeliverables.



The SiteExcellence Partnermay be required to support some orall ofthe primary responsibilities of theSite Relationship PartnerandCountryTrialsManager,as example, proactively collaborating and providing local intelligence to country outreach surveys, targeted sites strategies, study design, and Pfizer pipeline opportunities. The SiteExcellence Partnermay be required to support additional primary responsibilities of theSite Relationship Partnerinstudy 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 + 5 years of clinical research 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.



\#LI-PFE



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



Medical
Posted: 2021-06-01 Expires: 2021-07-02
Sponsored by:
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Site Excellence Partner

Pfizer
Mexico, MO 65265

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