Site Experience Partner

This is a unique opportunity to work in a dynamic environment where you will be responsible for building and retaining relationships with investigator sites throughout the lifecycle of studies. As a Site Care Partner, you will contribute to country and site selection activities by proactively collaborating with key stakeholders and providing local intelligence to country outreach surveys, investigator strategies, and Pfizer pipeline opportunities under supervision.

The role involves ensuring that sites receive necessary support and engagement, that issues are resolved, and Pfizer's reputation is upheld throughout study lifecycle. Additionally, the Site Care Partner will coordinate with other roles and functions that will interface with study sites (e.g., CRA, Investigator Contracts Lead, Site Activation Partner, cSOM, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities.

To achieve this, the Site Care Partner will utilize and interpret data from analytic tools (e.g., SQRD), in conjunction with country intelligence and IRMS to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.

Key Responsibilities:

• Deploy GSSO site strategies: Qualify and activate assigned sites.
• Simplify country & site selection activities: Support processes to optimize country and site selection activities including review and assessment of the draft potential site list and provide PTA output for site selection.
• Collaborate with key stakeholders: Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC, and medical practices (as applicable) under supervision.
• Conduct study start-up activities: Coordinate site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
• Ensure site initiation readiness: Ensure all the site initiation activity including training per site activation checklist, collect and complete necessary documentation/systems needed for site activation (e.g., PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF, etc.).
• Follow up post PTA and SIV: Ensure follow-up activities completion post PTA and SIV to ensure site readiness for FSFV.
• Site monitoring readiness: Partner with CRA/site monitor to ensure site monitoring readiness in anticipation of first subject first visit.
• Establish and maintain relationships: Establish and maintain relationships with Site Organizations and Strategic Partners.
• Escalated site issues: Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts (e.g., vendor, site contracts, and payment issues, etc.).
• IP and ancillary supplies strategy: Ensure the strategy/approach for IP and ancillary supplies for sites and country requirements throughout the lifecycle of the study.
• Effective site recruitment planning: Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible for enrollment delivery during study conduct.
• Country/local registry up-to-date: Partner with local RA/CTRO/SAP to ensure timely completion on country/local registry up to Site Activation.
• Quality and consistency in monitoring delivery: Assure quality and consistency in the delivery of monitoring.
• Positive Investigator relationships: Support the CRA/site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management.

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
• 5+ years of experience.
• Demonstrated experience in site management with prior experience as a site monitor/CRA.
• Demonstrated experience in start-up activities through to site activation.
• Demonstrated experience in conduct and close-out activities.
• Demonstrated knowledge of quality and regulatory requirements in applicable countries.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Good communication, presentation, and interpersonal skills.
• Ability to manage required travel.
• Demonstrated networking and relationship-building skills.
• Demonstrated ability to manage cross-functional relationships.
• Ability to communicate effectively and appropriately with internal and external stakeholders.
• Ability to adapt to changing technologies and processes.
• Knowledge of country requirements for GCP that may be different from those of Pfizer Procedures.
• Effectively overcoming barriers encountered during the implementation of new processes and systems.
• Identifies and builds effective relationships with investigator site staff and other stakeholders.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization.
• Able to manage issues that are escalated by site staff in a way that meets the needs of both Pfizer and the site staff.
• Fluent in Greek and English.