ICF (Informed Consent Form) Lead

Perform tasks at a global level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

As an ICF Lead you will oversee overall processes of ICF Development and associated project/study team activities:

Manage / author development and roll out of project instructions (global and country), templates, and supporting documentation including training materials to enable ICF development at master / country level
Coordinate implementation of changes to developmental processes and documentation when global / regional regulations impacting multiple countries arise
Implementation / roll out of ICF changes when new / revised ICF templates and guidelines are generated
Review Patient Informed Consent Form (ICF) for completeness and accuracy
Verify ICFs against Study protocol
Review, establish and agree on project planning and project timelines with sponsor and team
Distribute reviewed core level ICFs to ICF Specialists
Review, track and follow up the progress, the approval and execution of ICF documents
Review country level ICFs and adjust in accordance with study specific requirements
Review and provide feedback to management on the project status
Communicate key changes in these documents to a Sponsor
Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project specific information
Support team of ICF specialists in resolving their enquiries and provide cross-functional training and support as required
Act as a point of escalation

Qualifications
• Experience with ICF writing
• 1 year of clinical research experience in similar role at minimum or equivalent combination of education, training and experience is required.
• Ability to build strong relationships with stakeholders is essential, experience in sponsor facing role is strongly preferred
• Ability to lead the team on assigned projects
• Good analytical and organizational skills