Multiple United States – Remote
SAMPLE JOB SUMMARY (Search our Job Board for additional locations and specifics)
The Site Relationship & Excellence Partner is the main Pfizer point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, this role will utilize and interpret 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. This role is also accountable for identifying CRA performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place. The Site Relationship & Excellence Partner is the “face of Pfizer” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer’s reputation is that of “Partner of Choice.”
The Site Relationship & Excellence Partner proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Pfizer pipeline opportunities. This role is accountable for study start up, activation, and execution to the plan for targeted sites. In addition to the main point of contact, the lead will help 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.
Training 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 education/experience: 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 required.
Experience implementing centrally designed and developed initiatives on a local basis.
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 (preferred).
Site Management/Monitoring (CRA) experience (preferred).
Project management experience preferred in the clinical development area.
Ability to lead, troubleshoot and influence for delivery.
Demonstrated knowledge of quality and regulatory requirements for applicable countries.
Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation.
Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment.
Demonstrated success in prior scientific/technical/administrative roles.
Demonstrated experience in site activation.
Demonstrated networking and relationship building skills.
Demonstrated ability to manage projects and cross-functional processes.
Ability to communicate effectively and appropriately with internal & external stakeholders.
Ability to adapt to changing technologies and processes.
Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk.
Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development.
Proactively manages change by identifying opportunities and coaching self and others through the change.
Demonstrated ability to introduce new ideas and implement them.
Effectively overcoming barriers encountered during the implementation of new processes and systems.
Identifies and builds effective relationships with customers and other stakeholders.
Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration.
Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships.
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 competitive advantage.
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.
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.
Reports to Directors of Clinical Site Operations.
Indirect relationship with Study Management Group Lead and Targeted Investigator Network Strategy Implementation Lead.
Coordinates with institutions and investigators at the local level.
Coordinates with CRO at country/site level.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Availability to travel regularly within country and region is required.
Other Job Details:
Eligible for Employee Referral Bonus: YES