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/budgetary guidelines to develop the informed consent form (ICF), including during the maintenance phase.

Experienced professional individual contributor who works under mimimum supervision. May mentor or otherwise help newer team members navigate processes. Responsible for making adjustments or recommended enhancements in systems and processes to improve performance of job area. Problems faced are predominantly routine though occasionally non-routine.

Essential Functions
As an ICF lead, you will be responsible to oversee the 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
• 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
• Implementation / 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, 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 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

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

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