Senior Clinical Trial Associate

FSP-(Senior) Clinical Trial Associate-Client Office Based with Flexible Work From Home

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Senior Clinical Trial Associate at ICON Plc, you will support the management and execution of clinical trials by handling a range of administrative and operational tasks.

What You Will Do:

Prepare / submit clinical trial application dossier according to the given instruction from the responsible CSM / responsible CRAs while fully GCP, ICH, local regulations and Global Pharma SOP complaint and maintain in-house TMF submission documents properly.

Key responsibilities include:

• Prepare the EC/IRB submission for new / ongoing clinical trials
• Translate the global English study documents/tools(e.g. Informed consent
• Follow up the EC review status of assignedprojects
• Coordinate the response to EC queries and ensure the reply is timely submitted to EC
• Setup and maintain the submissiondossiers
• Serve as CTA hub contact to upload local documents for HA submission to REDI_AA and submit the completed dossier to HA
• May serve as a backup for IMP CPO contact defined in local SOP in term of clinical trial supplies management according to the assignment
• Align with CRAs/CSMs to generate the start up plan milestone dates and ensure that study milestones are met as planned (i.e. submission & approval date, startup, recruitment, closeout, etc).

Your Profile:

You will have a strong foundation in clinical trial management, with the experience to work independently and guide others.

Required qualifications and experience:

• Demonstrate ability to coordinate, organize andcommunicate
• Basic understanding of clinical development process including GCP and ICH fundamentals
• Proven ability to work on teams and deliver oncommitment
• At least two years IRB amendment experience, nice to have initial submission experience.
• Strong Team work and internalinfluence
• Basic Therapeutic areaknowledge.
• Communication withEC/HA

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

Rewards & Benefits

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 programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit ourcareers site to read more about the benefits ICON offers.

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.

Are you a current ICON Employee? Please clickhere to apply