Senior Clinical Study Start-Up Lead

ICON Clinical Research

City of Rome (NY)

Hybrid

USD 39,000 - 62,000

Full time

14 days+

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Job summary

ICON Strategic Solutions in Romania is seeking a Study Start Up Associate II to lead the initiation of clinical trials, ensuring regulatory compliance and contributing to the development of innovative treatments. You will work in a sponsor-dedicated model supported by ICON’s global expertise.

You will collaborate with internal and external stakeholders to prepare regulatory documents, obtain approvals, and maintain precise records, while supporting process improvements in study start-up

Qualifications

Bachelor's degree in life sciences or related field.
Minimum 2 years in clinical research or regulatory affairs with start-up experience.
Strong knowledge of regulatory requirements including ICH-GCP.
Excellent organizational and communication skills; ability to manage multiple tasks.
Willingness to travel approximately 5%.

Responsibilities

Lead site start-up and activation activities.
Prepare and submit regulatory documents (CTAs, ethics submissions, regulatory communications).
Coordinate with internal and external stakeholders for approvals.
Maintain records of regulatory submissions, approvals, and correspondence.
Provide guidance on regulatory requirements for start-up activities.
Participate in process improvements to streamline start-up.

Skills

Regulatory knowledge

Project management

Communication

Cross-functional collaboration

Travel readiness

Education

Bachelor's degree in life sciences

Job description

You will collaborate with internal and external stakeholders to prepare regulatory documents, obtain approvals, and maintain precise records, while supporting process improvements in study start-up

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