Site Care Partner, Senior Manager
PfizerAbout the role
The Site Care Partner is the main Pfizer 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 operational success, and accountable for safeguarding the quality
and patient safety at the investigator site. The Site Care Partner acts 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 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 upheld throughout study lifecycle.
Additionally, the Site Care Partner will coordinate with other roles and functions that will interface with study
sites (eg. Study 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 Partner is responsible for site oversight utilizing and interpreting data from analytic
tools, in conjunction with country intelligence to proactively identify risks to quality and compliance and to
develop and implement mitigation plans to address these risks. Site Care Partner Level 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 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. (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 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. (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 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
eg. recruitment, data entry timelines etc).
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).
Working with other roles, maintain system management (e.g., EDC , Shared Investigator Platform, Site Profile and
other systems as applicable) at site level en
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