Site Care Partner II

JOB SUMMARY

The Site Care Partneris a keyPfizer point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies; accountable for site-level recruitment and accountable for safeguarding the quality and patient safety at the investigator site. The Site Care Partneracts as a Subject Matter Expert aimed to optimize 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. The Site Care Partneris accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer’s reputation is upheld throughout study lifecycle. Additionally, the Site Care Partnerwill coordinate with other roles and functions that will interface with study sites (eg. CRA/Site Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) thereby, optimizing communications and enhancing overall visibility into and confidence of quality of site level activities. The Site Care Partneris responsible for site quality utilizing and interpreting data from analytic tools, 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. Site Care PartnerLevel 2 may be expected to support Country Specific Activities that are required to assure end to end Clinical Trial Implementation (start up to close out).

JOB RESPONSIBILITIES

Accountable for site start-up and activation

• Deploy GSSO site strategies by qualifying and activating assigned sites
• Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.
• Supports 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 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. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
• Support country specific ICD review and deployment when applicable
• Ensure follow up activities’completion post PTA and SIV to ensure site readiness for FSFV Partners with CRA/site monitor to ensure site monitoring readiness in anticipation of first subject first visit
• Responsible for relationship building and operational qualityof the site
• 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.)
• 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 anddelivery, consistent with global and/or country plan and local targets; Jointly responsiblewith CRA/site monitorfor enrollment support during study conduct
• Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable
• Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners

Accountable for study conduct and close-out

• Review Site Reportsand related issues
• During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed. In addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site changes/issues occur to confirm that continuity and contingency plans are current.
• Inform and educate investigator sites of Pfizer pipeline opportunities that may be a good fit.
• Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g. home health, ePRO, DTP etc.
• Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership.

…