O pozici
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.
Co budeš dělat
- Responsible for delivery and/or may manage a team of employees responsible for executing site activation activities that may include:
- Site identification and feasibility activities, Regulatory, start-up, and maintenance activities
- Preparation, review, negotiation and management of site regulatory documentation and clinical trial agreements with sites and sponsors
- Maintains, reviews, and reports on site activation performance metrics
- Serves as the primary point of contact for investigative sites and/or sponsors;
- Ensures tracking completion of all regulatory and contractual documents for sites
- Establishes project timelines.
- Ensures all site activation activities are performed in accordance with all regulations, SOPs, Work Instructions and project requirements either at the global, regional, or country level and all relevant documents are submitted timely to the Trial Master File as per IQVIA/Sponsor requirements.
- Establishes and/or executes goals and objectives for team(s) as well as tracking and delivering on operational/financial performance.
- Participates in the broader Global Site Activation planning process; contributes to long-mid range goals and plans; and coordinates activities with other managers and their respective sub-families. Responsible for the development of complex contracting strategies, coordination of investigator grants, as applicable and proposal text to support the proposal development process.
- Develop contract and budget templates and contracting systems, tools, processes, and training materials
- Preparation, review, negotiation and management of site regulatory documentation and clinical trial agreements with sites and sponsors
- Serves as the primary point of contact for investigative sites and/or sponsors
- Ensures tracking completion of all regulatory and contractual documents for sites
Koho hledáme
- Bachelor’s Degree in Scientific discipline or Healthcare
- 3 to 5 years prior relevant experience
- Good negotiating and communication skills with ability to challenge.
- Thorough understanding of regulated clinical trial environment and knowledge of drug development process
- Goal oriented, self-starter with proven ability to work independently.
