Senior Study Manager - Infectious Disease/Vaccines (Remote)

ICON Strategic Solutions

United States

On-site

USD 120,000 - 160,000

Full time

14 days+

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Job summary

ICON plc in the United States/Canada is seeking a Senior Study Manager for Infectious Disease/Vaccines (Pragmatic Trials). You will serve as operational lead for trial execution, oversee the Clinical Trial Team, and coordinate with vendors and training activities to ensure timely delivery of study milestones.

The role requires 7+ years in clinical research with strong leadership, planning and communication skills, and global experience.

Qualifications

Seven plus years of clinical research experience with leadership responsibilities.
Experience directing trial delivery, from setup to closeout.
Strong communication, planning and cross-functional collaboration skills.
Familiarity with Pragmatic Trials, vaccines or infectious disease programs is preferred.
Global/regional clinical operations experience is highly valued.

Responsibilities

Operational point of contact for trial execution and all trial deliverables.
Leads Clinical Trial Team (CTT) and manages HQ operational activities.
Manages external vendor relationships (IVRS, PRO, etc.).
Plans Investigator meetings and protocol training.
Oversees budget alignment with protocol needs and trial execution within budget.
Sets up and maintains Trial Master File (eTMF).
Develops Site Monitoring Plan and study manuals.
Monitors recruitment planning, enrollment tracking and retention strategies.
Interfaces with Data Coordination and Data Management.
Ensures quality control and inspection readiness at all times.
Responsible for risk assessment, mitigation planning and execution.