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.
Associate Site Manager
Office based in Reading
Entry level opportunity
Engage in company training program to gain knowledge and skills required to independently conduct clinical remote monitoring visits and other clinical research activities in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Gain an understanding of all aspects of Real World Late Phase Research (RWLPR) site management and monitoring by striving to understand the work based on a combination of structured training programs, self-directed use of training materials and experience from study assignments.
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Gain experience with standard Quintiles tools, metrics and reports.
- Develop an understanding of how sites are staffed and operate in order to build strong relationships with personnel at assigned sites
- Gain experience in study procedures by working with experienced Site Management staff. May also work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
- Under close supervision, may perform site selection, start-up/regulatory, initiation, monitoring and close out visits in accordance with contracted scope of work, good clinical practices applicable regulations, SOPs and work instructions.
- Under close supervision, administer protocol and related study training to assigned sites and establish 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 to Clinical Project Manager (CPM), Site Management Lead (SML) and/or line manager.
- Under close supervision, manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrolment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
- 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, essential document collection and filing and other required study documentation.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Relevant educational background in life sciences / clinical research / drug development / medicine
- Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Strong written and verbal communication skills in applicable languages, and business level command of English
- Basic organizational, interpersonal and problem-solving skills
- Strong attention to detail
- Working time management skills
- Ability to establish and maintain effective working relationships with co-workers, managers and clients and site personnel at assigned sites
You will be contacted by one of our recruiters to arrange a prescreen call should your background be relevant for this opportunity who will be able to give you more information on this team and the opportunity and also explain the assessment process to you for this role.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
Job ID: R1088906