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 activity 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

Ability 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 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 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 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 Startup 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

Behavioral Competencies

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

Organizational Relationships:

Direct Report to DCSO

Indirect relationships with:

Global Study Manager/Study Operations Manager

Start Up PM

SAP

CTA

CTRO

ICL

Site Monitor/CRA

Feasibility Strategy and Analytics Lead

Signal Interpretation Lead

Coordinates with institutions and investigators at the country level.

Travel - As needed nationally and internationally.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.