Research Site Manager

3 giorni fa


Roma, Lazio, Italia Msd A tempo pieno

Job Overview

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The Clinical Research Associate role at MSD is a dynamic position that requires strong organizational skills, attention to detail, and effective communication. As a member of our team, you will be responsible for managing clinical research sites and ensuring compliance with regulatory requirements.

About the Job

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We are seeking a highly motivated and experienced individual to join our team as a Clinical Research Associate. In this role, you will be responsible for conducting site visits, monitoring study progress, and identifying and resolving issues related to protocol conduct, recruitment, and retention.

Responsibilities

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  • Perform site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, and associated documents.">
  • Conduct site visits, including validation visits, initiation visits, monitoring visits, close-out visits, and record visit & non-visit contact reports.">
  • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.">
  • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.">
  • Identify, assess, and resolve site performance, quality, or compliance problems and escalate per defined CRA Escalation Pathway as appropriate.">
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Requirements

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To be successful in this role, you will need:

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  • Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.">
  • B.A./B.S. with a strong emphasis in science and/or biology.">
  • Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.">
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.">
  • Ability to work independently across multiple protocols, sites, and therapy areas.">
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Benefits

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At MSD, we offer a competitive salary and benefits package, including:

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  • A base salary range of $65,000 - $80,000 per year.">
  • Health insurance, retirement plan, and paid time off.">
  • Ongoing training and professional development opportunities.">
  • Opportunities for career growth and advancement.">
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What We Offer

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We are proud to be an equal opportunity employer, committed to fostering an inclusive and diverse workplace. If you are a motivated and organized individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.



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