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Informed Consent Form Lead

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Primary Location: Sofia, Bulgaria Additonal Locations: Belgrade, Serbia,SRB; Bratislava, Slovakia,SVK Full time R1287517

Job description

IQVIA 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 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

#LI-BIANCAESTELLER

#LI-Hybrid

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. Learn more at https://jobs.iqvia.com

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