Essential Functions
- QC of project database(s) and requisition forms versus the sponsor protocol and sponsor specific requirements.
- Cross functional collaboration to ensure QC reviews reflect current process and quality standards. .
- Work with Set-up Managers and/or Project Managers and/or Set-up Coordinators to resolve problems or quality findings established during the QC review.
- Oversee and maintain adherence to QC timelines to ensure client needs are met.
- Analyze and identify quality trends and opportunities for training and process improvements.
- Collaborate with QC counterparts to ensure global consistency in the study set-up process. .
- Participate in external and internal audits as required.
- Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Qualifications
- Bachelor's Degree Science related field Req
- Minimum 2 years of clinical or research industry experience, including 1 year Set-up related and/or Project Management experience. Equivalent combination of education, training and experience.
- Possess strong interpersonal skills for interaction with senior internal stakeholders and on occasion senior members of sponsor organizations and demonstrated ability to meet deadlines.
- High attention to detail as demonstrated through a track record of achievement in the role of Set-up Manager, Senior Set-up Specialist, Project Manager or equivalent.
- Demonstrated computer proficiency with Microsoft Office, Q Squared Solutions systems and ELVIS.
- Possess an understanding of medical and clinical research terminology.
- Demonstrated ability to work in a fast paced, deadline driven environment. . Knowledge of Set-up Management and/or Project Management processes and terminology would be beneficial.
- Excellent organizational skills and operational skills.
- Excellent written and verbal communication skills including good command of the English language.
- Ability to establish and maintain effective working 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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
