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About the Role

This role involves investigating potential clinical trial investigators and sites, managing trial agreements, overseeing patient enrollment, collecting and relaying safety information, preparing essential documents, creating monitoring reports, verifying case report forms against medical records, and managing trial close-out procedures. The position also includes gathering information on development products and competitors.

Responsibilities

Investigate potential clinical trial investigators and sites.
Manage clinical trial requests and contracts.
Request enrollment according to the enrollment plan at each clinical trial facility and confirm the enrollment status.
Collect adverse event information at clinical trial facilities and transmit safety information to clinical trial facilities.
Prepare and exchange essential documents.
Prepare monitoring reports.
Verify case report forms against medical records.
Manage clinical trial closing procedures.
Collect information on development products and competing products.

Requirements

Communication skills with physicians and Clinical Research Coordinators (CRCs).
Proactive and cooperative attitude to act spontaneously as a member of the internal project team.
Presentation skills to understand and explain Investigator's Brochures, protocols, etc.
Basic knowledge of general medical fields.
Ability to perform duties in cooperation with other departments of the Global R&D Headquarters.
Computer skills in PowerPoint, Word, and Excel.
English proficiency (TOEIC 730 or higher: ability to conduct business via email).

Skills

Clinical Data Management
Clinical Trials Monitoring
Drug Development
English Language
Good Clinical Practice (GCP)
Japanese Language
Pharmaceutical Testing
Problem Solving
Regulatory Compliance
Teamwork
PowerPoint
Word
Excel

Location

Hybrid

Work Type

Hybrid

Education Level

Physician
CRC

About the Company

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products.
The company has a legacy of over a century, driven by innovation and inventiveness.
Success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.