Full Job Description
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Seeking a Clinical Research Associate II with Medical Device experience.
Objective of the job
To manage, initiate, monitor and close the clinical sites participating in clinical research in compliance with the regulatory requirements, timelines, applicable guidelines (ICH-GCP, ISO 14155, FDA 21 CFR) and genae SOPs under the supervision of the clinical project manager and/ or sponsor.
To monitor and validate study data, whether on site or in-house according to the applicable SOPs and requirements outlined in the clinical investigational plan (CIP) (if any);
To ensure the participating sites perform clinical research according to the regulatory requirements, timelines, applicable guidelines (ICH-GCP, ISO 14155, FDA 21 CFR) and CIP requirements;
To report on the activities and provide site and patient status information in a timely manner to the Clinical Project Manager;
To attend and contribute to project meetings and trainings as required;
To ensure that project management tracking systems/ databases remain updated;
To act as an intermediary that facilitates a timely and accurate communication flow between the involved parties which may include genae employees, clinical sites, sponsors and third-party vendors;
To pro-actively identify project related issues and discuss strategies with the Clinical Project Manager on how to handle these efficiently;
To represent genae in a professional manner at all times; interfaces with internal and external customer.
Perform miscellaneous job-related duties as assigned
Education: Higher educational degree (BSc, MSc) in a medical or science-related field; pharmacy, nursing or equivalent healthcare professional qualification preferred.
Experience: At least one (1) year of clinical research experience as a Clinical Research Associate, a Data Reviewer or a Study Coordinator or equivalent.
Clear, effective written and verbal communication;
Fluent in English, by preference in more languages;
Pro-active problem solver;
Strong organizational, planning, collaboration and team-building skills;
Ability to work according and towards expected timelines and within budget;
Computer proficiency with Microsoft Office;
Data analysis skills: interpret data and communicate the importance of it, present facts and defend recommendations logically, give context to all corners of the team, be able to set strategies and priorities and address sub-optimal performance.
The working conditions will involve regular up to intensive national and international travelling.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com to arrange for such an accommodation.