Experience Inc. Jobs

Job Information

IQVIA ICF Lead in Sofia, Bulgaria

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

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled

DirectEmployers