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The Site Care Partneris 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 Responsibility:
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 investigatorsites 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 OperationsManager/Global Study Manager
Provide regional exploration/territory development growing adjacent opportunities where possible
Provide support to the Study OperationsManager/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)
Proficiency in local language preferred. English is required
Work as SCP I experience above 2 years
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