IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources, and extensive domain expertise.
Your responsibilities
Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with the contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
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 as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support the start-up phase.
Ensure copies/originals (as required) of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, and generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting the development of project subject recruitment plan on a per-site basis.
If applicable, may be accountable for site financial management according to the executed clinical trial agreement and retrieve invoices according to local requirements.
Training & development
Advancing healthcare requires people who are willing to explore new ideas, build on successes, and learn from mistakes. Some of the learning & development that IQVIA provides:
Training systems
AI talent marketplace tool
Leadership training programs
Employee recognition programs
Mentorship programs
Benefits
Benefits of working at IQVIA include:
Health & well-being
Medical, dental, and vision coverage
Critical illness coverage
Prescription coverage
Disability, accidental death, pet and life insurance
Employee Assistance Programs
Mental health support
Well-being programs and events
Flexibility & time off
Flexible work environment
Learning & development
Community engagement
Retirement and savings plans
Career progression
They are always learning and seeking opportunities for personal, professional, and organizational growth. At IQVIA, you are encouraged to grow and stretch into new opportunities. This could mean climbing the traditional career ladder, or exploring various therapeutic areas and/or other clinical career paths across monitoring, project management, site activation, operations, and more!
Work-life balance
IQVIA understands life’s complexities so no matter the role, they strive to find the balance of work flexibility so you can succeed both professionally and personally.
IQVIA is deeply rooted in the healthcare industry, and its culture reflects a commitment to improving human health. Employees often feel a sense of purpose in contributing to advancements in healthcare through their work.
About you
Bachelor's Degree in a scientific discipline or health care preferred.
Prior on-site monitoring experience; or equivalent combination of education, training, and experience.
Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Good therapeutic and protocol knowledge as provided in-company training.
Computer skills including proficiency in the use of Microsoft Word, Excel, and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
How to apply
Please click on the "Apply on employer site" button to apply.
Source/s:
youtube.com
iqvia.com
Hiring criteria
You should have or be completing the following to apply for this opportunity.
Entry Pathway
Degree or Certificate
Minimum Level of Study
Bachelor or higher
Study Field
M
Audiology & Speech Pathology
Biomedical Science
Chiropractic & Osteopathy
Dentistry & Dental Science
Exercise & Sports Science
Health Administration
Work rights
The opportunity is available to applicants in any of the following categories.