Accountable for site start-up and activation
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.
Conduct study start up activities at the site level including but not limited to PTA, SIV (as applicable), including management of issues that may compromise time to site activation and/or initiation.
Partners with pCRO/monitor to ensure site activation and support site monitoring readiness in anticipation of first subject first visit. Responsible for relationship building and operational management
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.
Act as operational point of contact for all site level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
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
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
Responsible for proactively providing local intelligence
Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable).
Provide input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes, practices, and associated site performance metrics.
Provide regional exploration/territory development growing adjacent opportunities where possible.
Provide support to the Country Trials Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies (as applicable).
Responsible for CRO and Study Management Interface
Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Activation Partner, Site Excellence Partner, Country Trials Managers and Study Management.
The Site Relationship Partner may be required to support some or all of the primary responsibilities of the Site Excellence Partner, as described in the Site Excellence Partner Job Description. Including but not limited to: safeguarding quality and patient safety at the investigator site, site and monitoring oversight, and utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.
Qualifications and Skills
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 with 5+ years of clinical research experience and/or quality management experience. A nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience.
Skills in more than one language are an advantage in this role. English is required.
Experience with study start-up activities through site initiation and activation
Experience with drug development and monitoring
Experience implementing centrally designed and developed initiatives on a local basis