Descrizione : Site Relationship Partner. Azienda : Pfizer. Posizione : Roma, Lazio
ROLE SUMMARY The Site Relationship Partner is the main Pfizer point of contact for investigative sites; accountable for site start-up activities; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies. The Site Relationship 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 Relationship Partner proactively collaborates with key stakeholders and provides local intelligence to country outreach surveys, investigators strategies, and Pfizer pipeline opportunities. Additionally, the Site Relationship 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
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 CRA to ensure monitoring readiness in anticipation of first subject first visit.
Responsible for relationship building and operational management • Support 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 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. • Demonstrate leadership within the local clinical development environment with a goal to enhance Pfizer reputation in scientific leadership. • Actively pursue possible efficiencies and develop best practices in the delivery activities for site start up and performance at the site level to increase investigator/site satisfaction and strengthen site relationships with Pfizer. • Seek assignment to complex protocols due to demonstrated capability in responsibilities
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 country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required. • Provide input into country strategy/planning and site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics. • Provide input to cluster level intelligence for site strategy and support implementation of cluster-level strategy in collaboration with the Country Trials Manager • 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.
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 Manager 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
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 + 7 years of clinical research experience and/or quality management experience. • Proficiency in local language preferred. English is required.
Prior Experience • Experience with study start-up activities through site initiation • Experience with drug development and monitoring • Experience implementing centrally designed and developed initiatives on a local basis
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
Behavioral Competencies • 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 • Acts as a mentor to other Site Relationship Partner.
LAST DAY TO APPLY: March 19 2021
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