Senior Study Start Up Associate

ICON Strategic Solutions; Deutschland; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Life assurance

Employee assistance program (LifeWorks

Annual leave entitlements

Job summary

ICON Strategic Solutions is seeking a Senior Study Start Up Associate to join a sponsor-dedicated model, contributing to the development of plans for country and site distribution within a fast-paced environment.

You will lead on-site start-up and activation tasks with a focus on quality, regulatory submissions, and safeguarding patient welfare, while collaborating with international teams across jurisdictions.

Qualifications

• Bachelor's degree in Medical/Science field or equivalent.
• Minimum 3 years of clinical study start-up experience.
• Fluency in local language and English.
• Willingness to travel up to 5%.

Responsibilities

• Lead on site start-up and activation tasks with a focus on quality.
• Conduct feasibility assessments, site identification, contract negotiations, and SSU activities.
• Provide SSU expertise to team leads and project teams to drive success.
• Coordinate regulatory submissions and ensure compliance with guidelines.
• Support the development and review of essential documents to safeguard patient welfare.

Skills

Site start-up

SSU expertise

Regulatory compliance

Clinical trial coordination

Travel readiness

Education

Bachelor's degree in medical/science

Job description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Study Start Up Associate at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start Up Team Lead in developing and execute the plan for country and site distribution.

What You Will Do

You will lead on site start-up and activation tasks requiring technical depth, with a focus on quality and continuous improvement.

Key Responsibilities Include

• Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
• Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
• Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
• Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

Your Profile

You will have a strong foundation in site start-up and activation, with the experience to work independently and guide others.

Required Qualifications And Experience

• A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.
• At least 3 years of experience or understanding of clinical study start-up requirements and activities, showing your expertise in the field.
• Fluency in the local language and English is essential, enabling you to effectively communicate and collaborate with international teams.
• Willingness to travel as required (approximately 5%)

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here