Jahn Estarellas
Clinical Site Manager | Clinical Research Management, IQVIA FSP AMGEN
- Role
- Clinical Site Manager Cra-fsp Amgen at IQVIA
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About Jahn Estarellas
Extensive experience in pharmaceutical clinical research and patient education. Skilled…
Experience
Clinical Site Manager Cra-fsp Amgen
Oct 2024 — Present · US
Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Build awareness of features and opportunities of study to site.• Collaborate and liaise with study team members for project execution support as appropriate
Education
Butler University
Doctor's Degree, Pharmacy
Universidad de Puerto Rico
Bachelor's degree, Biology, General
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.