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Job OverviewJoin 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 planswith sites, ensuring project needs are met with precision and predictability.
• Lead protocol and study training sessionsfor assigned sites, establishing strong communication channels to manage project expectations and swiftly address issues.
• Evaluate and ensure the highest qualityof study site practices, maintaining strict adherence to protocols and regulations. Escalate quality issues as needed to uphold excellence.
• Oversee the progress of studiesby tracking regulatory submissions, approvals, recruitment, enrollment, case report form (CRF) completion, and data query resolution. Support the start-up phase with enthusiasm.
• Maintain meticulous documentationfor 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 reportson 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 seamlesslywith study team members to support project execution and ensure success.
• Develop and manage subject recruitment planson a per-site basis, if applicable.
• Handle site financial managementaccording to clinical trial agreements and retrieve invoices as per local requirements, if applicable.
  

Qualifications

• Bachelor’s Degreein a scientific discipline or health care preferred.
• At least 11 months of on-site monitoring experiencerequired.
• Expert knowledgeof clinical research regulatory requirements, including GCP and ICH guidelines.
• Strong therapeutic and protocol knowledgeas 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 relationshipswith 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.