Pfizer - Remote, OR

posted 3 months ago

Full-time - Mid Level
Remote, OR
Chemical Manufacturing

About the position

The Site Care Partner serves as the primary point of contact for investigative sites throughout the lifecycle of clinical studies at Pfizer. This role is crucial in ensuring that site start-up activities are executed efficiently, leading to successful site activation. The Site Care Partner is responsible for building and maintaining strong relationships with investigator sites, providing ongoing support from the initial site recommendation through to the completion of studies. This includes overseeing site-level recruitment and operational success while safeguarding the quality and safety of patients at the investigator sites. As a Subject Matter Expert, the Site Care Partner collaborates proactively with key stakeholders, offering local insights that inform country outreach surveys, investigator strategies, and opportunities within the Pfizer pipeline. In this capacity, the Site Care Partner is the face of Pfizer, ensuring that sites receive the necessary support and engagement throughout the study lifecycle. This involves coordinating with various roles and functions that interact with study sites, such as Study Monitors, Investigator Contracts Leads, and Site Activation Partners, to enhance communication and visibility into site-level activities. The Site Care Partner utilizes data from analytic tools and country intelligence to identify potential risks to quality and compliance, developing and implementing mitigation plans as needed. For those at Site Care Partner Level 2, there may be additional responsibilities related to Country Specific Activities to ensure comprehensive Clinical Trial Implementation from start-up to close-out. The role encompasses a wide range of responsibilities, including site start-up and activation, supporting feasibility strategies, conducting study start-up activities, and ensuring effective site recruitment and operational oversight. The Site Care Partner acts as the operational point of contact for site-level inquiries, manages site practices, and maintains regular communication with investigator sites to drive progress towards study goals. Additionally, the Site Care Partner is responsible for reviewing site monitoring reports, managing site deliverables, and ensuring compliance with Pfizer practices and regulatory requirements. This position requires a proactive approach to identifying and addressing challenges, fostering positive relationships with investigators, and contributing to the overall success of clinical trials at Pfizer.

Responsibilities

  • Accountable for site start-up and activation.
  • Deploy GSSO site strategies by qualifying and activating assigned sites.
  • Support processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.
  • Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices.
  • Conduct study start up activities at the site level including PTA, coordination of site activation checklist items, ICD finalization, and SIV management.
  • Ensure all site initiation activities are completed, including training and necessary documentation for site activation.
  • Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
  • Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals.
  • Act as operational point of contact for all site-level questions, liaising with appropriate teams to respond and resolve questions.
  • Review and manage site practices that differ from Pfizer practices and liaise with study management as needed.

Requirements

  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience with approximately 7+ years of experience.
  • Demonstrated experience in site management with prior experience as a site monitor.
  • Demonstrated experience in start-up activities through to site activation.
  • Demonstrated experience in conduct and close-out activities.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
  • Demonstrated networking and relationship-building skills.
  • Ability to adapt to changing technologies and processes.

Nice-to-haves

  • Proficiency in local language preferred; English is required.
  • Experience in decentralized capabilities at investigator sites such as home health, ePRO, DTP.

Benefits

  • 401(k) plan with Pfizer Matching Contributions
  • Paid vacation, holiday, and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits including medical, prescription drug, dental, and vision coverage
  • Participation in Pfizer's Global Performance Plan with a bonus target of 15% of the base salary
  • Eligibility to participate in share-based long-term incentive program
  • Relocation assistance may be available based on business needs and/or eligibility.
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