The Site Care Partner is the main Pfizer point of contact for investigative sites; accountable for through 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. The Site Care Partner is the “face of Pfizer” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer’s reputation is that of “Partner of Choice.” The Site Care Partner proactively collaborates with key stakeholders and provides local intelligence to country outreach surveys, investigator strategies, and Pfizer pipeline opportunities. Additionally, the Site Care Partner will help coordinate with other roles and functions that will interface with study sites, thereby, simplifying communications and enhancing overall visibility into and confidence of quality of site-level activities. Also, the SCP will coordinate with other roles and functions that will interface with study sites (eg. Study monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) SCP responsible for the Site Oversight identify risks to quality and compliance and to develop and implement mitigation plans to address these tasks.

Accountable for site start-up, conduct and close out visit

• Deploy GSSO site strategy (e.g., insourced/targeted) by qualifying and activating assigned sites, while coordinating Pfizer functions to standardized processes and deliver site activation.

• Supports processes to optimize country and site selection activities

• Conduct study start up activities at the site level including but not limited to PTA, SIVs., ICD finalization including management of issues that may compromise time to site activation and/or initiation.

• Ensure all the site activation activities including trainings, etc.

• Point of contact for all site-level questions, liaising and escalating to appropriate teams to respond and resolve questions.

• Review Site Monitoring Reports

• Support assigned investigator sites through site close out.

• Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts by colleagues.

• Lead effective site recruitment planning, consistent with global and/or country plan and local targets; Provide enrollment support and ensure progress by responding to recruitment issues from investigators.

• Maintain regular communications with investigator sites to gather status updates.

• Maintain system management (e.g., Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms.

• Review and manage site practices that differ from Pfizer practices and liaise with study teams and study management.

• Inform and educate investigator sites of Pfizer pipeline opportunities that may be a good fit.

• Support development and delivery of decentralized capabilities at investigator sites

• May act as a Subject Matter Expert on Pfizer systems and processes

BASIC QUALIFICATIONS

Training and Education

• A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology.  In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience.

• Skills in more than one language are an advantage in this role. Advanced  English is required.

PREFERRED QUALIFICATIONS

Prior Experience

• Experience with study start-up activities through site initiation, activation and close-out.

• Experience with drug development and monitoring

• Experience implementing centrally designed and developed initiatives on a local basis

Skills and Technical Competencies

• Demonstrated knowledge of quality and regulatory requirements for applicable countries

• Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation

• Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment

• Demonstrated success in prior scientific/technical/administrative roles

• Demonstrated experience in site activation

• Demonstrated networking and relationship building skills

• Demonstrated ability to manage projects and cross-functional processes

• Ability to communicate effectively and appropriately with internal & external stakeholders

• Ability to adapt to changing technologies and processes

• Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development

• Proactively manages change by identifying opportunities and coaching self and others through the change

• Demonstrated ability to introduce new ideas and implement them

• Effectively overcoming barriers encountered during the implementation of new processes and systems

• Identifies and builds effective relationships with customers and other stakeholders

• Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships

• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

• Ability to manage required travel of up 75% on a regular basis

 
Work Location Assignment: Flexible

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, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer

EEO (Equal Employment Opportunity) & Employment Eligibility 

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.