job title: Informed consent specialist 2

What you'll be doing:

• Developing and reviewing ICFs: Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations.

• Ensuring compliance: Applying proficient knowledge of ICON SOPs/WPs, ICH/GCP guidelines, and applicable country regulations related to Informed Consent requirements.

• Stakeholder collaboration: Serving as a key point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and other functional leads to optimize performance and ensure successful project outcomes.

• Query resolution: Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to country and site-specific ICFs.

• Timeline management: Forecasting and tracking SIS & ICF approval timelines, proactively identifying risks, and developing contingency plans to mitigate potential impacts.

• Knowledge leadership: Acting as a Subject Matter Expert (SME) for assigned topics, staying updated on changing regulatory and language requirements affecting ICFs, and developing/conducting training.

• Documentation and archiving: Ensuring the accuracy and completeness of ICF documents transferred for filing into the Trial Master File (TMF).

• Mentorship: Mentoring and coaching new hires during their onboarding process.

• Representing FSA: Representing the department at audits, inspections, and on various committees and work groups.

Your profile:

• Minimum 2 years of experience in ICF writing/development.

• Strong English writing and and communication skills are required.

• Proficient knowledge of ICH/GCP guidelines and applicable country regulations related to Informed Consent.

• Ability to work collaboratively in a team environment and effectively communicate with diverse stakeholders.

• Strong analytical and problem-solving skills, with excellent attention to detail.

• Protocol interpreting & review is preferred, but not required.