RWE Associate Site Manager

8 miesięcy temu

Warsaw, Polska IQVIA Pełny etat
Associate Site Manager with French

Real-World Evidence

Hybrid: EMEA

Join us on our exciting journey

IQVIA Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers, and patients.

Our approach is unique in the industry and is defining the way companies develop and apply real-world evidence for healthcare decision making.

We are collaborative, intellectually curious, entrepreneurial, and constantly looking for opportunities to harness the value of real-world evidence in an evolving industry.

Due to continued growth, we are seeking new brave minds to join our award winning and innovative department.

Overview

Under the direction and guidance of the Real-World Late Phase Research Clinical Operations Lead, Line Manager or Project Manager, conduct clinical remote monitoring visits and other clinical research activities in accordance with Study Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (ICH GCP) and applicable regulatory requirements. Gain an understanding of all aspects of Real-World Late Phase Research, Site Management and Site Monitoring.

Responsibilities

Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites. Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology. Perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs, and work instructions. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Operations Lead (COL) and/or Line Manager. Manage and follow study activities through ongoing tracking and review of study progress. Report progress to Line Management and Project team. Manage the progress of assigned studies by documenting recruitment and enrolment, Case Report Form (CRF) completion and submission, and data query generation and resolution. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation. Gain experience with standard IQVIA tools, metrics, and reports.

Qualifications

Bachelor's Degree preferably in life science/ health care, or equivalent combination of education, training, and experience. Prior relevant experience will be an asset. Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is preferred. Excellent written and verbal communication skills including good command of English & French language . Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint. Organizational, planning, interpersonal, and problem-solving skills. Strong attention to detail. Time management skills. Ability to establish and maintain effective working relationships with co-workers, managers and clients and site personnel at assigned sites.

What is in it for you?

Global exposure Variety of therapeutic areas Collaborative and supportive team environment Access to cutting-edge in-house technology Excellent career development and progression opportunities Work-Life Balance

JOIN US

Embrace your curiosity and grow your career in an exciting environment where development is a priority. Think boldly and disrupt conventional thinking. Enjoy what you do.

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

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