Job Overview
Support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities.
Essential Functions
- Develop simple investigator grant estimates and proposal text to support the proposal development process.
- Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
- Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
- Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
- Assist in the creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
- Contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required.
- Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.
- Comply with contract management and quality standards. Provide administrative and operational support to investigator site contract analysts, managers and directors as required.
- Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
Qualifications
- Bachelor's Degree
- Minimum 2 years of site contracting experience, including CTA (Clinical Trial Agreement) handling.
- Manage initial and amendment CTA drafting, review, negotiation, and execution.
- Lead site budget development and negotiations with investigational sites.
- Coordinate contract and budget negotiations to ensure timely execution.
- Coordinate investigator grants, proposal documentation, and contracting strategies for study start-up activities.
- Life sciences or medically related field including biopharmaceuticals clinical research experience.
- Strong communication and stakeholder management skills.
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.