Informed Consent Form Lead

Informed Consent Form Lead
Company:

Iqvia


Place:

Gauteng


Job Function:

Strategy / Planning

Details of the offer

QVIA is the Human Data Science Company™ oriented to drive human health outcomes forward.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 levelCoordinate implementation of changes to developmental processes and documentation when global / regional regulations impacting multiple countries ariseImplementation / roll out of ICF changes when new / revised ICF templates and guidelines are generatedReview Patient Informed Consent Form (ICF) for completeness and accuracyVerify ICFs against Study protocolReview, establish and agree on project planning and project timelines with sponsor and teamDistribute reviewed core level ICFs to ICF SpecialistsReview, track and follow up the progress, the approval and execution of ICF documentsReview country level ICFs and adjust in accordance with study specific requirementsReview and provide feedback to management on the project statusCommunicate key changes in these documents to a SponsorEnsure accurate completion and maintenance of internal systems, databases, and tracking tools with project specific informationSupport team of ICF specialists in resolving their enquiries and provide cross-functional training and support as requiredAct as a point of escalationQualifications• 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 skillsIQVIA 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. Learn more at


Job Function:

Requirements

Informed Consent Form Lead
Company:

Iqvia


Place:

Gauteng


Job Function:

Strategy / Planning

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