Remote Job ICON plc Hiring Informed Consent Specialist II in India. Apply for clinical research documentation and ICF writing jobs today.
Company: ICON plc
Location: Bangalore, Chennai, Trivandrum (India) – Office or Remote
Job Title: Informed Consent Specialist II
Qualification: Life Sciences / Pharmacy Graduate (B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc)
Experience: Minimum 2 Years in ICF Writing / Development
Employment Type: Full-Time | Clinical Operations | Regulatory Documentation
Job ID: JR136801
Posted On: 4 Days Ago
Verified: Verified Job via ICON Careers
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to advancing clinical development through data, technology, and scientific expertise. The company partners with global biopharmaceutical organizations to accelerate clinical research and bring innovative therapies to patients faster. With operations across 100+ countries, ICON provides an inclusive, collaborative, and innovation-driven work environment that empowers professionals to thrive in their careers. Remote Job ICON plc Hiring Informed Consent Specialist II
Job Overview
ICON plc is seeking a highly skilled Informed Consent Specialist II to join its expanding team in India. This role offers a hybrid or remote work setup, providing flexibility while contributing to global clinical trials. Remote Job ICON plc Hiring Informed Consent Specialist II
As an Informed Consent Specialist, you will play a key role in preparing, reviewing, and approving Informed Consent Forms (ICF) and Subject Information Sheets (SIS). Your work will ensure compliance with global regulatory requirements and uphold ethical standards in clinical research. Remote Job ICON plc Hiring Informed Consent Specialist II
Key Responsibilities
- Developing and Reviewing ICFs: Prepare, review, and approve master, country-specific, and site-specific ICFs and SIS documents.
- Ensuring Compliance: Apply in-depth understanding of ICH-GCP guidelines, ICON SOPs, and local regulatory standards.
- Stakeholder Collaboration: Serve as a liaison between Sponsors, Project Managers, Clinical Trial Managers, and Ethics Committees.
- Query Resolution: Review, negotiate, and resolve all IRB/IEC and Competent Authority queries related to informed consent.
- Timeline Management: Forecast and track ICF approval timelines while identifying risks and implementing mitigation strategies.
- Knowledge Leadership: Act as a Subject Matter Expert (SME) for informed consent processes and provide training to team members.
- Documentation & Archiving: Ensure completeness and accuracy of ICF documentation for submission to the Trial Master File (TMF).
- Mentorship: Guide and mentor new hires during onboarding and skill development.
- Representation: Participate in audits, inspections, and departmental committees as an FSA representative.
- Remote Job ICON plc Hiring Informed Consent Specialist II
Required Qualifications & Skills
- Minimum 2 years of experience in ICF writing, development, or regulatory documentation.
- Strong command of English writing and communication skills.
- Sound understanding of ICH-GCP guidelines and country-specific regulations related to informed consent.
- Ability to interpret clinical protocols and translate technical information into clear patient-facing language.
- Strong analytical, organizational, and problem-solving skills with high attention to detail.
- Ability to work effectively both independently and in cross-functional global teams.
Why Join ICON plc
At ICON, you will be part of a global community that values innovation, inclusion, and excellence. The company’s culture is centered around professional growth, collaboration, and employee well-being. Remote Job ICON plc Hiring Informed Consent Specialist II
ICON Offers:
- Competitive salary packages and performance-based rewards.
- Annual leave and flexible work arrangements (office or remote).
- Health insurance and wellness programs for you and your family.
- Retirement planning benefits and financial security schemes.
- Access to the Global Employee Assistance Programme (TELUS Health) for mental and emotional well-being support.
- Employee benefits like childcare vouchers, discounted gym memberships, and subsidized travel passes.
- A workplace free from discrimination, fostering inclusion and belonging.
How to Apply
Interested candidates can apply directly through the ICON Careers portal. Ensure your resume highlights your experience in Informed Consent Form (ICF) writing, ICH-GCP knowledge, and clinical documentation. Remote Job ICON plc Hiring Informed Consent Specialist II
Whether you meet all the listed qualifications or not, ICON encourages you to apply — your skills and experience might be the perfect fit for this or future roles within the organization. Remote Job ICON plc Hiring Informed Consent Specialist II
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