Site Care Partner

The Site Care Partner is a key Pfizer point of contact for investigative sites throughout a study life cycle.

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
• Provide country/regional level input to country strategy, feasibility and protocol design
• Maintain a knowledge of assigned protocols
• Conduct study start up activities at the site level including PTA, coordination of site activation checklist items, ICD finalization, SIV
• Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation
• Support country specific ICD review and deployment when applicable
• Ensure follow up activities’completion post PTA and SIV to ensure site readiness for FSFV
• Responsible for relationship building and operational quality of the site
• Provide study support on escalated site issues related to study delivery
• 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
• Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable
• Responsible for establishing and maintaining relationships with Site Organizations and Strategic Partners

Accountable for study conduct and close-out:

• Review Site Reports and related issues
• During the conduct of the study, the Site Management Organization Assessment is reviewed with the site
• Inform and educate investigator sites of Pfizer pipeline opportunities
• Support development and delivery including issue resolution of decentralized capabilities at investigator sites
• Demonstrate leadership within the local clinical development environment
• May act as a Subject Matter Expert on Pfizer systems and processes
• Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance
• Ensures clear and open communication with Study Operations Manager
• Support the CRA/site monitor to develop positive Investigator relationships

Responsible for proactively providing local intelligence:

• Provide input into country strategy/planning and site recommendations
• Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy
• Provide regional exploration/territory development growing adjacent opportunities where possible
• 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: least 7 years’ experience
• Ability to manage required travel
• Proficiency in local language preferred, English is required
• 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
• Excellent communication, presentation and interpersonal skills
• 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
• Effective in managing cross functional relationships