Pfizer Inc. Site Excellence Partner II in Billings, Montana
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 CRA performance issues and are
responsible for ensuring appropriate corrective and preventative actions
are put in place.
Job ResponsibilitiesResponsible for process, standards, and oversight:
Responsible for site and monitoring quality, regulatory and GCP
Drive inspection readiness and provide support for site
audits/inspections as needed, following through audit/inspection finding
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
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
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
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.
QUALIFICATIONS / SKILLSTraining and 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
BS/BSc/MS/MSc or equivalent + 7 years of clinical research experience
and/or quality management experience
Skills in more than one language are an advantage in this role. English
is essentialPrior Experience
Solid knowledge of clinical development processes with strong emphasis
Demonstrated ability to oversee a 3rd party and/or demonstrated ability
in Quality Assurance (preferred)
Site Management/Monitoring (CRA) experience (preferred)
Project management experience preferred in the clinical development
Ability to lead, troubleshoot and influence for delivery
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
environmentAbility 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
Considers stakeholders including regulatory agencies and marketing when
developing strategies and future directions
Challenges people to surpass themselves in reaching their objectives
using innovative solutions
Utilizes and encourages innovative approaches to build and maintain a
Acts as a champion of change across the area/region/countries; uses
facts, logic and personal credibility to influence the successful
implementation of process improvements
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
Motivates through example, commitment, loyalty and enthusiasm
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Availability to travel regularly within country and region is
Last Date to Apply: April 16th, 2021
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hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility:
Pfizer is committed to equal opportunity in the terms and conditions of
employment for all employees and job applicants without regard to race,
color, religion, sex, sexual orientation, age, gender identity or gender
expression, national origin, disability or veteran status. Pfizer also
complies with all applicable national, state and local laws governing
nondiscrimination in employment as well as work authorization and
employment eligibility verification requirements of the Immigration and
Nationality Act and IRCA. Pfizer is an E-Verify employer.