Clinical Operations Specialist

Regulatory Jobs; Center Square (PA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Competitive base salary

Health, dental, vision coverage

Retirement plan

Life and disability insurance

Employee assistance programs

Training and career development

Job summary

ICON Strategic Solutions is seeking a Clinical Operations Specialist to join our sponsor-dedicated team in advancing study start-up activities. You will lead regulatory submissions, drive approvals, and ensure compliant start-up processes across trials, contributing to patient access to innovative therapies.

The role requires 2+ years in clinical research or regulatory affairs, strong organizational skills, and the ability to collaborate with diverse teams. Expect travel around 5% as needed.

Qualifications

• Bachelor's degree in life sciences or related field.
• 2+ years in clinical research or regulatory affairs, with study start-up experience.
• Knowledge of regulatory requirements and ICH-GCP guidelines.
• Strong organizational and project management skills.
• Excellent communication and collaboration with cross-functional teams.
• Willingness to travel ~5%.

Responsibilities

• Lead the preparation and submission of regulatory documents, including CTAs, ethics submissions, and agency communications.
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain comprehensive, accurate records of regulatory submissions, approvals, and correspondence.
• Provide guidance and support to study teams on regulatory requirements and best practices for study start-up.
• Participate in process improvement initiatives to streamline study start-up processes and increase efficiency.

Skills

Communication

Project management

Regulatory affairs

Travel willingness

Cross-functional teamwork

Education

Bachelor's degree in life sciences

Job description

Clinical Operations Specialist

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 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:

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

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.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
• 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.

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 requesthere.