Site Budget and Contract Lead

This is a fully remote position, open to applicants in Romania.

📋 Description

• Oversee the creation of investigator budgets and contract proposals.

• Act as the primary liaison for budget and contract discussions with investigator sites and Sponsors.

• Prepare draft clinical budgets for new research studies.

• Create and manage country-specific, sponsor-approved minimum and maximum budget grids.

• Develop tailored Clinical Trial Agreement templates for specific projects that meet country and sponsor standards.

• Facilitate the negotiation and signing of site budgets and contracts with investigators, Legal Affairs, and Sponsors as necessary.

• Manage contract and budget amendments throughout the course of trials.

• Update tracking systems to streamline site payments.

• Participate in internal and client project team meetings.

• Collaborate with Project Management, Regulatory Affairs, Legal Affairs, Finance, CTMS, and other internal teams.

• Ensure that fully executed contract deliverables are completed promptly in accordance with study schedules.

• Assist Regulatory Affairs in reviewing informed consent templates to ensure subject compensation text aligns with approved study budgets.

• Facilitate negotiations and communications with sites through contractors, sub-CROs, or CRAs when necessary.

• Provide oversight to contractors, Sub-CROs, and Innovaderm/Indero SBCS across various countries.

• Serve as the functional lead for contract management in global studies and the main point of contact for Sponsors.

• Ensure total study budgets remain within scope and escalate any out-of-scope requests to Sponsors.

• Communicate with sites in local languages when feasible.

• Maintain training and compliance with internal processes and SOPs.

• Engage in departmental projects and contribute expertise in site budget and contracting.

• Mentor junior team members as a subject matter expert.

• Assist the Manager of Site Selection and Contracting in delivering exceptional project outcomes.

⛳️ Requirements

• Bachelor's degree in a relevant field related to clinical research or equivalent experience.

• At least 4 years of experience in clinical research with a focus on site budget/contract negotiation within the biotechnology, pharmaceutical, or CRO industry, including substantial and relevant experience in site selection, study start-up activities, and/or close collaboration with sites or in a site environment.

• Minimum of 2 years’ experience in a comparable contract lead role in the biotechnology, pharmaceutical, or CRO industry.

• Proficient in written and spoken English.

• Bilingual in Spanish, German, or Polish; proficiency in two or more EU languages is advantageous.

• Strong capability to manage multiple projects simultaneously, organize work efficiently, and perform under pressure to meet deadlines.

• Excellent knowledge of the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).

• Ability to thrive under pressure and manage tight timelines.

• Quick learner who is adaptable and versatile.

• Ability to work effectively in a team environment and build strong relationships with colleagues, sponsors, and sites.

• Well-organized, capable of managing competing priorities, and able to work in a fast-paced, evolving environment.

• Flexibility, a positive attitude, exceptional attention to detail, and critical thinking skills.

• Legally authorized to work in the Czech Republic.

🏝️ Benefits

• Permanent full-time position.

• Flexible work schedule.

• Vacation time.

• Home-based position.

• Continuous learning and development opportunities.

• Attractive prospects for career advancement.

• Accommodations available throughout the recruitment and selection process for applicants with disabilities, upon request.