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 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 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.
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 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 up to Site Activation.
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.
Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners.
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 for enrollment delivery during study conduct.
Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry up to Site Activation.
Accountable for study conduct and close-out
Review Site Reports and related issues.
Assure quality and consistency in the delivery of monitoring.
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 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
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
5+ years experience.
Demonstrated experience in site management with prior experience as a site monitor/CRA.
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.
Good 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.
Able to manage issues that are escalated by site staff in a way that meets the needs of both Pfizer and the site staff.
Fluent in Greek and English.
Work Location Assignment: Remote
Purpose
Breakthroughs 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.
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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 Opportunity
We 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 Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
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