Job Overview Join our dynamic medical devices team and take on the exciting challenge of monitoring and managing sites for a variety of cutting-edge protocols. Be at the forefront of innovation and make a real impact in the medical devices field!

Essential Functions

• Embark on site monitoring adventures (selection, initiation, monitoring, and close-out visits) in line with contracted scope of work and regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Drive and track subject recruitment plans with sites, ensuring project needs are met with precision and predictability.

• Lead protocol and study training sessions for assigned sites, establishing strong communication channels to manage project expectations and swiftly address issues.

• Evaluate and ensure the highest quality of study site practices, maintaining strict adherence to protocols and regulations. Escalate quality issues as needed to uphold excellence.

• Oversee the progress of studies by tracking regulatory submissions, approvals, recruitment, enrollment, case report form (CRF) completion, and data query resolution. Support the start-up phase with enthusiasm.

• Maintain meticulous documentation for the Trial Master File (TMF) and verify the Investigator’s Site File (ISF) is up to standard with GCP/ICH and local regulatory requirements.

• Create comprehensive reports on site management, monitoring visit findings, and action plans. Submit regular visit reports, follow-up letters, and other essential study documentation.

• Mentor and inspire clinical staff , conducting co-monitoring and training visits to share knowledge and expertise.

• Collaborate seamlessly with study team members to support project execution and ensure success.

• Develop and manage subject recruitment plans on a per-site basis, if applicable.

• Handle site financial management according to clinical trial agreements and retrieve invoices as per local requirements, if applicable.

Qualifications

• Bachelor’s Degree in a scientific discipline or health care preferred.

• At least 11 months of on-site monitoring experience required.

• Expert knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.

• Strong therapeutic and protocol knowledge as provided in company training.

• Proficiency in Microsoft Word, Excel, and PowerPoint , and adept at using laptops and mobile devices (iPhone and iPad where applicable).

• Excellent communication skills , both written and verbal, with a good command of the English language.

• Outstanding organizational and problem-solving skills .

• Effective time and financial management skills .

• Ability to build and maintain effective relationships with coworkers, managers, and clients.

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 $73,780.00 - $174,468.00. 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.

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 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