Clinical Study Team Associate

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.

The Clinical Study Team Assistant (CSTA) is an essential part of the Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and SOPs. The role collaborates with global study team members and is responsible for multiple tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high quality standards. 

What You Will Do:

You will lead on clinical coordination tasks requiring technical depth, with a focus on quality and continuous improvement.
Key responsibilities include:

• Management and oversight of Study Team shared spaces

• Trial Master File (TMF) maintenance, compliance, and oversight

  • Analyze, interpret, and follow up on metrics

• Management and oversight of Study Team on Demand (STOD)

  • Analyze, interpret, and follow up on metrics

• Maintain Pfizer registries and systems as required to ensure compliance

• Tracking and oversight of study information; follow up with functional lines as needed

• Liaising with cross functional study team members:

  • Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems

  • Provide study level reporting to support management of clinical trial data, clinical trial budget and timelines 

• Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission

• Support engagement of Independent Oversight Committees

• Provide support with audit and inspection readiness activities

• Assist with oversight and tracking of Clinical Trial Budget spend

• Provide logistical and operational support for Investigator Meetings

• Coordinate the translation of documents as required

• Provide status updates on key tasks and contribute to the Study Team Meetings as an active Study Team member 

• Provide support to study teams with system setup and maintenance

• May provide support for global study team communications to sites

Your Profile:

You will have a strong foundation in clinical coordination, with the experience to work independently and guide others.
Required qualifications and experience:

• 1-3 years exp with BA/BS or 1+ years exp with MA/MBA/MS

• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)

• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research

• Science background

• Experienced with clinical trial processes and applicable systems

• Effective verbal and written communication skills

• Ability to work independently but also as part of a larger team with limited support from supervisor

• Ability to multitask and manage multiple competing priorities

• Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality

• Knowledge of drug development process

• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.

• Good problem solving & decision-making skills: Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems

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 click here to apply