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
Engage in company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
IQVIA clinical FSP business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our clients. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.
Leadership recognises the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.
Unique to the FSP model, our team contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’. Additionally, IQVIA’s FSP business works with the Sponsors SOP’s, creating more continuity for both parties.
Our models offer excellent opportunities for experienced CRA’s to expand their knowledge and skills.
Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Gain experience in study procedures by working with experienced clinical staff.
Under close supervision, perform site selection (if applicable), initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.
If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas to CRA for improving site recruitment plan in line with project needs to enhance predictability. Assist CRA in tracking subject site recruitment progress.
Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
Under close supervision, 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. Under close supervision may support start-up phase.
Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Convey features and opportunities of study to site.
Collaborate and liaise with study team members for project execution support as appropriate.
All responsibilities are essential to job functions unless noted as non-essential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Excellent written and verbal communication skills including good command of English and Dutch language
Good organizational and problem-solving skills
Effective time management skills
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree, preferred in health care or other scientific discipline, or equivalent combination of education, training and experience
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.