Site Care Partner

This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.TheSite Care Partneris a key Pfizer point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through site 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 contributes to 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 under supervision. The Site Care Partner is accountable for ensuring that sites receive necessary support and engagement, that 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, Investigator Contracts Lead, Site Activation Partner, cSOM, 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 (eg SQRD), 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. Job Responsibilities: Accountable for site start-up and activation Deploy GSSO site strategies by qualifying and activating assigned sitesSupports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision.Maintain a knowledge of assigned protocolsConduct 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 up to Site ActivationEnsure follow up activity completion post PTA and SIV to ensure site readiness for FSFVPartners with CRA/site monitor to ensure site monitoring readiness in anticipation of first subject first visitResponsible for relationship building and operational quality of the siteResponsible for establishing and maintaining relationships with Site Organizations and Strategic PartnersAbility to write scientific summary documents for Subject expert committee and present to the SEC in India and defend protocols.Have a scientific outlook to coordinate with local Medical affairs, Regulatory and Local Commercial teams for global and local studies.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 studyBe accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly Responsible with site monitor/CRA for enrollment delivery during study conductPartner with local RA/ CTRO / SAP to ensure timely completion on country / local registry up to Site ActivationAccountable for study conduct and close-out Review Site Reports and related issuesAssure quality and consistency in the delivery of monitoringSupport 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 site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.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 / SKILLS Education Graduate or Post-Graduate in Pharmacy or Biotechnology or Nursing degree.MBBS/MD or in a related field with 8 - 12 years of experienceProficiency in local language preferred. English is required.Experience Demonstrated experience in Site Management with prior experience as a Site Monitor/CRADemonstrated experience in Startup activities through to Site ActivationDemonstrated experience in conduct and close out activitiesDemonstrated knowledge of Quality and Regulatory requirements in applicable countriesSkillsand Technical Competencies Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirementsMust demonstrate good computer skills and be able to embrace new technologiesGood communication, presentation, and interpersonal skillsAbility to manage required travelDemonstrated networking and relationship building skillsDemonstrated ability to manage cross functional relationshipsAbility to communicate effectively and appropriately with internal & external stakeholdersAbility to adapt to changing technologies and processesKnowledge of country requirements for GCP that may be different to those of Pfizer ProceduresBehavioral Competencies Effectively overcoming barriers encountered during the implementation of new processes and systemsIdentifies and builds effective relationships with investigator site staff and other stakeholdersEffective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organizationAble to manage issues that are escalated by site staff in a way that meets the needs of both Pfizer and the site staffOrganizational Relationships: Direct Report to DCSO Indirect relationships with: Global Study Manager/Study Operations ManagerStart Up PMSAPCTACTROICLSite Monitor/CRAFeasibility Strategy and Analytics LeadSignal Interpretation LeadCoordinates with institutions and investigators at the country level.Travel- As needed nationally and internationally. Work Location Assignment: HybridPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical