Study Operations Specialist
hace 23 horas
We are seeking a highly skilled Study Operations Specialist to join our team at Pfizer. This role is an exciting opportunity for individuals who want to work in a dynamic environment and contribute to the success of our studies.
Job Description
- Accountable for site start-up activities through activation, including qualification and deployment of assigned sites.
- Supports processes to optimize country & site selection activities, including review and assessment of draft potential site lists and providing output for site selection under supervision.
- Collaborates with key stakeholders to provide country/regional level input to country outreach surveys, including protocol feasibility, country SOP, and medical practices (as applicable) under supervision.
- Maintains a thorough knowledge of assigned protocols and conducts study start-up activities at the site level, including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), and management of issues that may compromise time to site activation.
- Ensures all site initiation activities, including training per site activation checklist, collection and completion of necessary documentation/systems needed for site activation (e.g., PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF).
- Supports country-specific ICD review and deployment when applicable.
- Ensures follow-up activities completion post-PTA and SIV to ensure site readiness for FSFV.
- Responsible for relationship building and operational oversight of the site.
- Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts (e.g., vendor, site contracts, and payment issues).
- Ensures the strategy/approach for IP and ancillary supplies for sites and country requirements throughout the lifecycle of the study.
- Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plans and local targets; responsible for enrollment support and ensures progress by responding to recruitment issues from investigators.
- Maintains regular communications with investigator sites to gather status updates and drive delivery to study goals (e.g., recruitment, data entry timelines).
- Partners with local RA/CTRO/SAP to ensure timely completion on country/local registry when applicable.
Requirements
- At least 5 years demonstrated experience in site management with prior experience as a site monitor.
- Demonstrated experience in start-up activities through to site activation.
- Demonstrated experience in conduct and close-out activities.
- Demonstrated knowledge of quality and regulatory requirements in applicable countries.
- Skills in more than one language are an advantage in this role. English is required.
What We Offer
This role offers a competitive salary range of $85,000 - $110,000 per year, depending on location and experience, plus benefits and opportunities for professional growth and development.
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