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Site Engagement Liaison
hace 2 semanas
As a S
ite engagement Liason, Based in Madrid or Barcelona you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
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
- Collaborate with key stakeholders providing country/regional level input to country outreach surveys including
- Maintain a thorough knowledge of assigned protocols
- Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist
activation.
- Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary
- 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 oversight of the site
- Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts. (e.g., vendor, site contracts and payment issues etc.)
- 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, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
- Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals eg. recruitment, data entry timelines etc).
- Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable
Accountable for study conduct and close-out
- Act as operational point of contact for all sitelevel questions, liaising with and escalating to appropriate teams to
- Review Site Monitoring Reports
- Support the site with revision and submission of ICD documents (and amendments).
- Working with other roles, maintain system management (e.g., EDC, Shared Investigator Platform, Site Profile and
- During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when
addition, the SMO Assessment is reviewed and updated when major staffing, contracting, or other significant site
changes/issues occur to confirm that continuity and contingency plans are current.
- Review and manage site practices that differ from Pfizer practices and liaise with study management and Business
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance
- Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database
- Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
- Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g.
- Assure quality and consistency in the delivery of monitoring
- Drive monitoring efficiencies and best practices for study/region/program
- Support shaping the local clinical development environment with a goal to enhance Pfizer reputation in scientific
- 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 site monitor to develop positive Investigator relationships throughout the life of the study and escalate
Responsible for proactively providing local intelligence
- Provide input into site recommenda
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