Senior Site Contract Associate - IQVIA Biotech

Senior Site Contracts Associate

IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. Agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.

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 and Skills

• Bachelor's Degree in life sciences or health care
• 5-7 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.