Job Overview:
Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements  at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines. With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with  applicable local and/or international
regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions:

With moderate oversight and supervision, serve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the  Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.

Prepare site documents, reviewing for completeness and accuracy.

Inform team members of completion of regulatory contractual. and other documents for individual sites.

Distribute completed documents to sites and internal project team members.

Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.

Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications:

Bachelor's Degree Life Sciences or a related field.

1 - 3 years’ clinical research or other relevant 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 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.

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.