Clinical Trial Operations Specialist

The Site Care Partner is a key point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation. They build and retain investigator site relationships, providing support from site recommendation through the lifecycle of studies. This role is responsible for site-level recruitment and safeguarding quality and patient safety at the investigator site.

This role acts as a Subject Matter Expert to optimize 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.

The Site Care Partner ensures that sites receive necessary support and engagement, issues are resolved, and Pfizer's reputation is upheld throughout the study lifecycle. They coordinate with other roles and functions that interface with study sites (e.g., CRA/Site Monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.), optimizing communications and enhancing overall visibility into and confidence of site level activities.

• Deploy GSSO site strategies by qualifying and activating assigned sites.
• Support processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.
• Support the Feasibility Strategy and Analytics Lead to ensure high-quality feasibility results are delivered.
• Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC, and medical practices (as applicable).
• Provide country/regional level input to country strategy, feasibility, and protocol design in collaboration with relevant Medical Affairs colleagues and external clinical experts.
• Maintain knowledge of assigned protocols.
• Conduct study start-up activities at the site level including PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), managing issues that may compromise time to site activation.
• Ensure all 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 when applicable.
• Ensure follow-up activities completion post-PTA and SIV to ensure site readiness for FSFV.
• Partner 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.
• Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
• Ensure the strategy/approach for IP and ancillary supplies for sites and country requirements 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 CRA/site monitor for enrollment support during study conduct.

Qualifications">

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
• 7+ years of experience.
• Demonstrated experience in site management with prior experience as a CRA/site monitor.
• 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.
• Excellent 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 and 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 overcome barriers encountered during the implementation of new processes and systems.
• Identify and build 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.
• Effective in managing cross-functional relationships.
• Fluent in Greek and English.

Work Location Assignment">

Remote