Accelerate innovation for a healthier world.
Senior Site Contract Associate
Location
Bulgaria
Posted
3 days ago
Salary
0
Seniority
Senior
Job Description
Senior Site Contract Associate
IQVIA
• 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. • 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.
Job Requirements
- 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.
Benefits
- 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.
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