Description
IQVIA Biotech is seeking a Senior Site Contracts Associate to support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs.
Job Overview The successful candidate will be responsible for supporting the delivery of all required start-up contracting activities, 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.
- Ensure collaboration 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.
- Assist in the creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance.
- Contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company.
- Ensure overall contracting efficiency and adherence to project timelines and financial goals.
- Comply with contract management and quality standards.
Qualifications and Skills
- Bachelor's Degree in life sciences or health care.
- +6 years relevant experience, including demonstrable experience acting as a contract negotiator.
- Relevant sponsor or clinical research organization clinical site contracting experience.
- Good negotiating and communication skills.
- Good interpersonal skills and a strong team player.
- Strong technical writing skills.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards.
- Good organizational and planning skills.
- Strong knowledge of Microsoft Office and e-mail applications.
- Ability to interpret pricing models and to prepare proposals, bid grids and budgets.
- Good understanding of clinical trial contract management.
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.