Senior Site Contracts Associate

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 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
• +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.