Internal Job Description

　　Job Overview

　　Leads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.

　　Manages the operational elements of clinical projects to deliver contracted clinical services to the customer’s satisfaction. Develops and maintains clinical project plans; accountable for subject recruitment, site management, and data integrity; and ensuring that appropriate recruitment strategies are in place.

　　Essential Functions:

　　Registration on clinicaltrials.gov

　　TMF Management Plan

　　Perform Functional checks and eTMF maintenance for study

　　Activate sites in GILDA

　　Preparing, handling, distributing, filing, and archiving of clinical documentation and reports as per the scope of work and standard operating procedures.

　　Assist the Study lead in providing a periodic review of the prospective principal investigators to be selected for participation in the study.

　　To ensure that the CRA transition documentation is complete.

　　Assist with periodic review of study files for accuracy and completeness.

　　Perform close out activities for study in close out phase. Perform administrative tasks to support team members with clinical trial execution as needed.

　　Assist the Quality Team with Monthly Investigator Quality reviews, mitigation strategy calls and preparation of Meeting minute

　　The Study Process Lead oversight activities will also include the day to day management of the CTA.

　　The Sr Study Process Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads partner with Project Leaders and other functional teams to secure delivery requirements are met at all times.

　　Sr Study Process Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.

　　Qualifications

　　Bachelor's Degree Life sciences or related field Req

　　+5 years of relevant experience.

　　Good knowledge of, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines

　　Advanced English level

　　Strong written and verbal communication skills

　　Results and detail-oriented approach to work delivery and output

　　Good problem solving, time management and prioritization skills

　　Proven ability to work on multiple projects balancing competing priorities

　　Good leadership skills

　　Ability to work across cultures and geographies with a high awareness and understanding of cultural differences

　　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

　　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.

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