Job Title: Clinical Document Specialist
Summary:
ICON plc, a global leader in healthcare intelligence and clinical development, is seeking a highly motivated and detail-oriented Clinical Document Specialist to join our team in India. This is a remote position offering an excellent opportunity to contribute to the success of clinical trials by ensuring the integrity, accuracy, and compliance of essential study documentation. If you possess a strong understanding of ICH-GCP guidelines, regulatory submission processes, and document lifecycle management, and are eager to advance your career in the pharmaceutical or CRO industry, we encourage you to apply.
About ICON plc:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We accelerate success in drug and device development from strategy to execution. Operating in 40 countries and powered by approximately 41,000 employees, we deliver for our clients through a constant pursuit of innovation. We believe that our people are our greatest asset, and we are committed to providing a supportive and rewarding work environment where they can thrive.
Job Overview:
As a Clinical Document Specialist, you will play a vital role in managing and maintaining clinical trial documentation, ensuring compliance with regulatory requirements and supporting the smooth execution of clinical studies. This position requires a proactive individual with excellent organizational, communication, and problem-solving skills.
Responsibilities:
- Manage, collect, review, and maintain essential trial documentation throughout the study lifecycle.
- Ensure adherence to ICH-GCP guidelines, FDA regulations, and other applicable regulatory standards.
- Coordinate and track the status of documentation, proactively identifying and resolving any gaps or discrepancies.
- Support internal and external audits by providing accurate and readily accessible documentation.
- Collaborate effectively with cross-functional teams, including clinical operations, data management, and regulatory affairs, to address documentation-related issues and ensure compliance.
- Contribute to the development and improvement of standard operating procedures (SOPs) and document management workflows.
- Maintain a thorough understanding of current regulatory requirements and industry best practices related to clinical documentation.
- Contribute to the overall quality and efficiency of the clinical trial process by ensuring the accuracy and completeness of essential documentation.
- Assist in the preparation and submission of regulatory documents.
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
- Proven experience in clinical research, regulatory affairs, or clinical document management.
- Strong knowledge of clinical trial documentation guidelines and quality systems.
- Familiarity with ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements.
- Excellent communication, interpersonal, and collaboration skills.
- Exceptional time management, organizational, and problem-solving abilities.
- Proficiency in using electronic document management systems and other relevant software applications.
- Experience working in a CRO or pharmaceutical environment is highly desirable.
- Ability to work independently and as part of a team.
- Detail-oriented and committed to maintaining high standards of accuracy and compliance.
Why Join ICON?
At ICON, we offer a competitive compensation package and a comprehensive benefits program that includes:
- Competitive salary and opportunities for career advancement.
- Remote work flexibility.
- Comprehensive health insurance and employee wellbeing programs.
- Generous annual leave and retirement benefits.
- Professional development support and training opportunities.
- A diverse and inclusive culture that fosters growth and innovation.
- Equal opportunities for all employees, regardless of background or experience.
- Opportunity to work on impactful projects that contribute to the advancement of healthcare.
- Global exposure and the chance to collaborate with talented professionals from around the world.
How to Apply:
If you are a motivated and detail-oriented individual with a passion for clinical research and regulatory documentation, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter through our online application portal. We look forward to hearing from you!