Senior Site Contract Associate - IQVIA Biotech

About the role

IQVIA Biotech supports biotech and emerging biopharma companies in clinical development across all phases and therapeutic areas. This Senior Site Contract Associate position is based at home and covers Bulgaria, Hungary and Romania. You will support the delivery of start-up contracting activities for selected sponsors, studies or multi-protocol programs, including pre-award work.

Key responsibilities

• Develop simple investigator grant estimates and proposal text to support proposal development.
• Maintain contract and budget templates, contracting systems, tools, processes and training materials according to the Scope of Work and Project Plan.
• Collaborate with sponsors, stakeholders and RSU regions and countries to deliver the project scope in line with sponsor requirements and the RSU Management Plan.
• Provide operational and financial contracting support to facilitate business development and the initiation and maintenance of clinical trials while meeting regulatory requirements.
• Help create and review core scientific, technical and administrative documentation needed for study initiation and maintenance.
• Contribute to collecting, interpreting and sharing contracting intelligence for assigned studies and the wider company.
• Ensure contracting efficiency, adherence to timelines and financial goals, and report performance metrics and out-of-scope activities.
• Comply with contract management and quality standards and support contract analysts, managers and directors administratively.
• Maintain internal systems, especially CTMS, databases, tracking tools, timelines and project plans accurately.

Required profile

• Bachelor's degree in life sciences or health care.
• At least 6 years of relevant experience, including demonstrable experience as a contract negotiator.
• Sponsor or clinical research organization clinical site contracting experience.
• Understanding of the regulated clinical trial environment and the drug development process.
• Ability to build effective working relationships with colleagues, managers and sponsors.

Required skills

• Good negotiating, communication and interpersonal skills, and strong technical writing.
• Knowledge of GCP/ICH and applicable regulatory guidelines, SOPs and corporate standards.
• Strong knowledge of Microsoft Office and e-mail applications.
• Ability to interpret pricing models and prepare proposals, bid grids and budgets.
• Good organizational and planning skills.