
Site Relationship Partner
3 semanas atrás
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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