Study Start-Up Specialist (TMF)

ICON Strategic Solutions; New Jersey; Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive base salary

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 professional to support global clinical trials and ensure studies run efficiently, compliantly, and on schedule.

You will partner with the Clinical Study Lead and cross‑functional teams to prepare actionable reports, coordinate meetings, and maintain TMF/CTMS data and documents while ensuring quality and regulatory compliance.

Qualifications

• 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 reports and metrics for study oversight and decision‑making.
• Coordinate meetings, agendas, presentations, and minutes.
• Analyze data to support feasibility assessments and site usability reviews.
• Manage study documents in line with SOPs (ICFs, CRFs).
• Maintain study manuals, binders, and version control.
• Coordinate investigator meetings and training activities.

Skills

Communication

Independent working

Tools

TMF

CTMS

SharePoint

PowerPoint

Excel

Job description

What You’ll Do:

As a key member of the clinical operations team, you’ll play a critical role in supporting the successful execution of global clinical trials. You will partner closely with the Clinical Study Lead and cross‑functional stakeholders to ensure studies run efficiently, compliantly, and on schedule.

Key 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

What You Bring:

Required 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

Work Location & Flexibility

• Hybrid office/home‑based role
• Must be open to working from one of the following locations: Warren, NJ; Armonk, NY; or Cambridge, MA

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programs including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programs and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Inclusion and Accessibility:

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.