ROLE SUMMARY
The Site Care Partner is a key 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 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 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. 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 Partner is 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 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 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 quality 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; Jointly responsible with CRA/site monitor for 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 Reports and 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.
May 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.
Ensures clear and open communication with Study Operations Manager.
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.
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.
QUALIFICATIONS
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
7+ years of experience.
Demonstrated experience in site management with prior experience as a CRA/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.
Must demonstrate good computer skills and be able to embrace new technologies.
Excellent 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 & external stakeholders.
Ability to adapt to changing technologies and processes.
Knowledge of country requirements for GCP that may be different to 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.
Effective in managing cross functional relationships.
Fluent in Greek and English.
Work Location Assignment: Remote
Purpose
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