Study Start Up Associate II
SSU 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.
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
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