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If you enjoy collaborating across line functions and want to strengthen your skillsets around TMF oversight, clinical study report (CSR) appendices authoring, and being part of a submission team, this could be a great fit for you!

As a core member of the global cross-functional Clinical Trial Team (CTT), supporting the Study Lead, assigned responsibilities can include but are not limited to:

• Creation and QC of CSR appendices
• Submission of CSR
• TMF oversight
• Develop specific sections of the protocol and related documents
• Create study tools, guidelines, and training materials
• Ensure trial information and results are reported.
• Support development of clinical outsourcing specifications
• Implement issue resolution plans
• Support cross functional teams
• Ensure proper handling of all study close out activities
• Participate in data review
• Education, implementation, and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s)
• Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards
• Proactive operational planning with effective contingency and risk mitigation plans

Requirements:

• Experience of handling DMS (Subway, CREDI, NCV)
• Experience in CSR appendices creation/ QC
• Good communication and project management skills (to track, coordinate the CSR appendix)
• Ability to work independently
• Advanced degree or equivalent education/degree in life science/healthcare recommended
• Basic knowledge of Good Clinical Practice, clinical trial design and scientific principles

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $82,400.00 - $186,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.