Job Description

Documents Specialist - India, Bangalore - Hybrid, Office-based

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 Clinical Document Specialist at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will take responsibility for clinical document management deliverables, applying your skills to ensure quality and efficiency.

Key responsibilities include:

• Manage the collection, review, and maintenance of essential documents required for clinical trials, ensuring compliance with regulatory standards and sponsor requirements.
• Coordinate document tracking and filing systems to facilitate efficient document management throughout the trial lifecycle.
• Assist in the development and implementation of document management processes and procedures to support study conduct and regulatory submissions.
• Collaborate with cross-functional teams to resolve document-related issues and ensure timely availability of accurate and complete documentation.
• Participate in internal and external audits and inspections, providing support for document-related queries and requests.

Your Profile:

You will bring relevant clinical document management experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree or higher in a relevant scientific discipline or healthcare-related field.
• Previous experience in clinical research, document management, or regulatory affairs within the pharmaceutical, biotechnology, or CRO industry.
• Familiarity with regulatory requirements and guidelines governing clinical trial documentation (e.g., ICH-GCP, FDA regulations).
• Strong organizational skills and attention to detail, with the ability to manage multiple tasks and priorities effectively.
• Excellent communication and interpersonal skills, with the ability to collaborate with stakeholders at all levels of the organization.

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