Job Overview

At a global level, drive Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines to develop the informed consent form (ICF), including during the maintenance phase.

Essential Functions

• Manage/author development and roll out of project instructions, templates, and supporting documentation, including training materials, to enable ICF development at master/country level.
• Partner key client accounts in the ICF development.
• Coordinate the implementation of changes to developmental processes and documentation when global/regional regulations impacting multiple countries arise.
• Implement/roll out of ICF changes when new/revised ICF templates and guidelines are generated.
• Review, establish, and agree on project planning and project timelines with sponsor and team.
• Review Patient Informed Consent Form (ICF) for completeness and accuracy.
• Verify ICFs against the study protocol.
• Distribute reviewed core level ICFs to ICF Specialists within country site activation.
• Review, track, and follow up the progress, 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 within the project or at a client level.

Qualifications

• Experience with ICF writing.
• 3 years 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.