By joining us as a Informed Consent Form Lead ( ICF) you will 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
- 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
