Site Budget and Contract Lead

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

📋 Description

• Oversee the creation of budget and contract proposals for investigators.

• Serve as the primary liaison for budget and contract discussions with investigator sites and sponsors.

• Manage project-related activities concerning contracts and budgets, engaging with clients as necessary.

• Cultivate and sustain relationships with clinical research sites and sponsors.

• Prepare preliminary clinical budgets for new studies.

• Create and maintain country-specific, sponsor-approved minimum and maximum budget grids for site negotiations.

• Draft project-specific Clinical Trial Agreement templates tailored to country and sponsor specifications.

• Facilitate the negotiation and finalization of site budgets and contracts with investigators, collaborating with Legal Affairs and sponsors when appropriate.

• Modify contracting processes to meet country-specific standards.

• Oversee contract and budget amendments throughout trials.

• Update tracking systems to streamline site payments.

• Participate in internal and client project team meetings as required.

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

• Ensure that all executed contract deliverables are completed promptly according to study timelines.

• Assist Regulatory Affairs in developing informed consent form master templates to ensure alignment of subject compensation text with approved study budgets.

• Facilitate site negotiations and communications via contractors, sub-CROs, or CRAs when needed by site location or language.

• Provide oversight to contractors, Sub-CROs, and Innovaderm SBCLs across various countries.

• Act as the functional lead for contract management in global studies and the main sponsor contact for contract management issues.

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

• Assist in communicating with sites in local languages when feasible.

• Ensure compliance with internal processes and SOPs through ongoing training.

• Contribute to departmental projects involving site selection, contracting, and other groups.

• Act as a subject matter expert and mentor junior team members in budget and contract negotiations.

• Support the Manager of Site Selection and Contracting in achieving project goals, scope, requirements, and quality results.

⛳️ Requirements

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

• At least 7 years of experience in clinical research, specifically in site budget/contract negotiation within the biotechnology, pharmaceutical, or CRO sectors.

• Significant and relevant experience in site selection, study start-up activities, and/or working closely with sites or in a site environment.

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

• Exceptional English written and verbal communication skills.

• Bilingual in Spanish, German, or Polish; proficiency in 2 or more EU languages is advantageous.

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

• Proficient in the Microsoft Office suite, including Word, Excel, PowerPoint, and Outlook.

• Prior clinical research experience in EU countries, along with knowledge of local regulations and processes, is a plus.

• Experience in dermatological and rheumatological clinical research is beneficial.

• Ability to thrive under pressure and meet tight timelines.

• Quick learner with good adaptability and versatility.

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

• Organized and capable of managing competing priorities in a fast-paced, dynamic environment.

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

• Legal authorization to work in the Czech Republic.

🏝️ Benefits

• Permanent full-time position.

• Flexible schedule.

• Vacation.

• Home-based position.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.

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