Senior Clinical Trial Associate

Responsibilities

• 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 assigned projects
• Coordinate the response to EC queries and ensure the reply is timely submitted to EC
• Setup and maintain the submission dossiers
• 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 and communicate
• Basic understanding of clinical development process including GCP and ICH fundamentals
• Proven ability to work on teams and deliver on commitment
• At least two years IRB amendment experience, nice to have initial submission experience.
• Strong Team work and internal influence
• Basic Therapeutic area knowledge.
• Communication with EC/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 our careers 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

Benefits

Additional Information

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.

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