Site Care Partner

Pfizer, S.A. de C.V; Ciudad de México; Híbrido; MXN 600,000 - 800,000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical company seeks a Site Care Partner in Mexico City. This crucial role involves managing relationships with investigative sites, ensuring effective communication, and overseeing site start-up and activation activities. Candidates should possess a Bachelor’s degree or RN and at least 5 years of relevant experience. Proficiency in English is required, and proficiency in the local language is preferred. This position offers a hybrid work arrangement with opportunities to contribute to crucial clinical trials.

Servicios

Competitive compensation

Benefits programs

Formación

• At least 5 years of experience in site management.
• Proficiency in English and local language preferred.
• Experience with study start-up and close-out activities.

Responsabilidades

• Accountable for site start-up activities and site activation.
• Ensure site-level recruitment and safeguard quality.
• Build and maintain relationships with investigators.

Conocimientos

Good Clinical Practice knowledge

Communication skills

Presentation skills

Interpersonal skills

Networking skills

Computer skills

Educación

Bachelor’s degree or RN in a related field

Descripción del empleo

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Work Location Assignment:Mexico City, Mexico. Must be able to work from assigned Pfizer office 2-3 days per week, or as needed by the business

JOB 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 (e.g. 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 (e.g. 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.

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

Work Location Assignment: Hybrid

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 with site monitor/CRA 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 elevate 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

Educationh3>

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience)

Proficiency in local language preferred. English is required

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

Skills and Technical Competencies

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

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

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