Global Clinical Study Start-Up Specialist

ICON Strategic Solutions; New Jersey; Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health and wellbeing programs

Retirement and pension plans

Life assurance and disability coverage

Learning and development opportunities

Job summary

ICON Strategic Solutions is seeking a Clinical Operations support professional in a hybrid role based in Warren, NJ. You will partner with the Clinical Study Lead and cross-functional teams to ensure global trials run efficiently, compliantly, and on schedule.

You will prepare reports, coordinate meetings, and support TMF/CTMS activities while maintaining accuracy and adherence to SOPs. This position emphasizes data analysis, document management, and vendor coordination.

Qualifications

• Minimum of 2 years of relevant industry experience in clinical research or clinical operations.
• Experience supporting global clinical trials across regions (NA, LAM, EU, APAC, India).
• Hands-on experience with TMF, CTMS, and SharePoint.
• Strong written and verbal communication skills with excellent attention to detail.
• Self-motivated, solution-oriented, and comfortable working independently with minimal supervision.
• Experience reviewing Informed Consent Forms (ICFs).
• Proficiency in PowerPoint and Excel, including meeting documentation and reporting.

Responsibilities

• Prepare, organize, and deliver clear, actionable reports and metrics to support study oversight and decision-making.
• Plan, coordinate, and support clinical study team and related meetings, including agendas, presentations, and meeting minutes.
• Collate and analyze data to support feasibility assessments and site selection activities, including review of site usability databases.
• Support the review and management of study documents (e.g., Informed Consent Forms, Case Report Forms) in compliance with SOPs.
• Compile and maintain study manuals and reference binders (regulatory, pharmacy, laboratory, etc.), ensuring accurate version control.
• Coordinate materials and logistics for investigator meetings and study training activities.
• Track site activation, enrollment, and monitoring visits against project plans; proactively flag risks, delays, and deviations.
• Maintain investigator and site status, including support for clinical trial registry postings.
• Perform scheduled Trial Master File (TMF) reconciliations in partnership with the Clinical Study Lead.
• Track required reports and documentation, including 1572 changes and financial disclosure forms.
• Manage and maintain team SharePoint sites and shared drives, ensuring information is current and well organized.
• Communicate with clinical sites as directed and maintain accurate site contact records.
• Support line listings review for Blind Data Review Meetings (BDRM).
• Contribute to oversight and coordination of third‑party vendors, as needed.
• Track close‑out activities, including documentation, investigational product reconciliation, financial disclosures, and CRA close‑out visits.
• Participate in SOP updates and departmental initiatives.
• Proactively identify and recommend process improvements to enhance efficiency and quality.

Skills

Communication skills

Attention to detail

Independent worker

Tools

TMF

CTMS

SharePoint

PowerPoint

Excel

Job description

ICON Strategic Solutions is seeking a Clinical Operations support professional in a hybrid role based in Warren, NJ. You will partner with the Clinical Study Lead and cross-functional teams to ensure global trials run efficiently, compliantly, and on schedule.

You will prepare reports, coordinate meetings, and support TMF/CTMS activities while maintaining accuracy and adherence to SOPs. This position emphasizes data analysis, document management, and vendor coordination.