Site Relationship Partner
1 semana atrás
The Site Relationship 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 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, investigator 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. Also, the SRP will coordinate with other roles and functions that will interface with study sites (eg. Study monitor, Investigator Contracts Lead, Site Activation Partner, Clinician, etc.) SRP 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-
- 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 communicati
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