Site Care Partner I

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 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.Responsibilities:Accountable for site start-up and activationDeploy 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 know edge of a signed 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 activities’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 firstvisitResponsible for relationship building and operationalqualityof the siteResponsible for establishing and maintaining relationships with Site Organizations and StrategicPartnersProvide study support on escalated site issues related to study delivery by coordinatingcommunications 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 requirementthroughout the lifecycle of the studyBe accountable for effective site recruitment planning and delivery, consistent with global and/orcountry plan and local targets; Jointly Responsible with site monitor/CRA for enrollment delivery duringstudy conductPartner with local RA/ CTRO / SAP to ensure timely completion on country / local registry up to SiteActivationAccountable for study conduct and close-outReview 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 thestudy 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 ancillarysupplies.

Qualifications

:Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience(strong experience preffered)Proficiency in local language preferred. English is requiredDemonstrated experience in site management with prior experience as a site monitor/CRADemonstrated experience in start up activities through to site activationDemonstrated experience in conduct and close out activitiesDemonstrated knowledge of quality and regulatory

Requirements

in applicable countriesWork Location Assignment: Remote - Field BasedPurposeBreakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment OpportunityWe believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.DisAbility ConfidentWe are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career.

Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.MedicalOriginally posted on Himalayas