Site Care Parter

$109,400 - $182,300/Yr

Pfizer - New York, NY

Full-time - Mid Level

New York, NY

Chemical Manufacturing

About the position

The Site Care Partner is 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 and that investigator site relationships are built and maintained effectively. The Site Care Partner is responsible for site-level recruitment and operational success, ensuring that quality and patient safety are prioritized at the investigator site. Acting as a Subject Matter Expert, the Site Care Partner collaborates with key stakeholders to optimize country and site selection activities, providing local intelligence that informs country outreach surveys, investigator strategies, and Pfizer's pipeline opportunities. As the 'face of Pfizer', the Site Care Partner ensures that sites receive the necessary support and engagement, resolves issues promptly, and upholds Pfizer's reputation throughout the study lifecycle. In addition to these responsibilities, the Site Care Partner coordinates with various roles and functions that interface with study sites, such as Study Monitors and Investigator Contracts Leads, to enhance communication and visibility into site-level activities. The role involves oversight of site operations, utilizing data from analytic tools to proactively identify risks to quality and compliance, and developing mitigation plans to address these risks. The Site Care Partner Level 2 may also support country-specific activities necessary for the comprehensive implementation of clinical trials, from start-up to close-out. The responsibilities include deploying GSSO site strategies, supporting feasibility strategy and analytics, maintaining knowledge of assigned protocols, conducting study start-up activities, ensuring site readiness for first subject first visit, and managing site deliverables to meet study targets. The Site Care Partner is also accountable for effective site recruitment planning and delivery, maintaining regular communication with investigator sites, and providing input into country strategy and site recommendations. This role requires a proactive approach to managing relationships with investigator site staff and ensuring compliance with regulatory requirements, ultimately contributing to the 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.
• Support the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered.
• Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable).
• Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required.
• Maintain a thorough knowledge of assigned protocols.
• Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
• Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation.
• Support country specific ICD review and deployment when applicable.
• Ensure follow up activities completion post PTA and SIV to ensure site readiness for FSFV.
• Partner with site monitor to ensure site monitoring readiness in anticipation of first subject first visit.
• Responsible for relationship building and operational oversight of the site.
• Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
• Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study.
• Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
• Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals.
• Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable.
• Accountable for study conduct and close-out.
• Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
• Review Site Monitoring Reports.
• Support the site with revision and submission of ICD documents (and amendments).
• Maintain system management at site level ensuring alignment across platforms.
• Review and manage site practices that differ from Pfizer practices and liaise with study management and Business Process Owners as needed.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
• Inform and educate investigator sites of Pfizer pipeline opportunities that may be a good fit.
• Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables.
• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
• Support development and delivery including issue resolution of decentralized capabilities at investigator sites.
• Assure quality and consistency in the delivery of monitoring.
• Drive monitoring efficiencies and best practices for study/region/program.
• Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership.
• Act as a Subject Matter Expert on Pfizer systems and processes.
• Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships.
• Ensure clear and open communication with Study Operations Manager.
• Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager and Study Management.
• Responsible for proactively providing local intelligence.
• Provide input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.
• Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with the Study Operations Manager/Global Study Manager.
• Provide regional exploration/territory development growing adjacent opportunities where possible.
• Provide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies.

Requirements

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years 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.
• Demonstrated knowledge of quality and regulatory requirements in applicable countries.
• 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.
• Demonstrated ability to manage cross functional relationships.
• Ability to communicate effectively and appropriately with internal & external stakeholders.
• Ability to adapt to changing technologies and processes.

Nice-to-haves

• Vaccine experience preferred.
• Proficiency in local language preferred. English is required.

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
• Relocation assistance may be available based on business needs and/or eligibility