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 Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.
What You Will Do:
You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.
Key responsibilities include:
- Work directly with assigned sites on all site related essential document collection and review.
- Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
- Ensure standards are applied to the SSU processes across projects.
- Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
- Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
- Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
- Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
- Review and provide feedback to management on site performance metrics.
- Ensure accuracy and completeness of the eTMF for assigned sites during start up
Your Profile:
You will bring relevant site start-up and activation experience, along with the following qualifications and skills.
Required qualifications and experience:
- Bachelor's degree in life sciences or a related field.
- 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
- Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Willingness to travel as required (approximately 5%)
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
Skills Required
- Bachelor's degree in life sciences or a related field.
- 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
- Excellent organizational and project management skills, with ability to prioritize and manage multiple tasks.
- Excellent communication and interpersonal skills, with ability to collaborate effectively with cross-functional teams.
- Willingness to travel as required (approximately 5%).
- Legal right to work in the country where the role is based.
ICON plc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.
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Healthcare Strength — Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
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Leave & Time Off Breadth — Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
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Retirement Support — Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.
ICON plc Insights
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
