Site Budget and Contract Lead

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

📋 Description

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

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

• Coordinate all project-related activities concerning contracts and budgets.

• Build and sustain relationships with clinical research sites and Sponsors.

• Prepare draft clinical budgets for new research studies.

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

• Create project-specific Clinical Trial Agreement templates tailored to the requirements of different countries and sponsors.

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

• Oversee contract and budget modifications throughout the trials.

• Update tracking systems to streamline site payment processes.

• Attend internal and client project team meetings as required.

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

• Ensure timely completion of all executed contract deliverables in alignment with study timelines.

• Assist Regulatory Affairs in reviewing informed consent templates to ensure alignment with approved study budgets.

• Support site negotiations and communications through contractors, sub-CROs, or CRAs when needed.

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

• Serve as the functional lead and sponsor contact for contract management in global studies.

• Guarantee that total study budgets remain within the agreed scope and escalate any out-of-scope requests to Sponsors.

• Communicate with sites in local languages whenever feasible.

• Maintain training and adherence to internal processes and SOPs.

• Participate in departmental projects related to site selection, contracting, and associated activities.

• Act as a subject matter expert and mentor for junior team members.

• Assist the Manager of Site Selection and Contracting to ensure high-quality project outcomes.

⛳️ Requirements

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

• A minimum of 4 years of experience in clinical research, specifically in site budget and contract negotiations 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.

• At least 2 years of experience in a similar contract lead role within the biotechnology, pharmaceutical, or CRO industry.

• Exceptional written and spoken English skills.

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

• Strong capacity to manage multiple projects, effectively organize work, and operate under pressure and tight deadlines.

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

• Prior clinical research experience in EU countries and familiarity with local regulations and processes is beneficial.

• Experience in dermatological and rheumatological clinical research is an advantage.

• Ability to perform well under pressure and meet tight timelines.

• Quick learner with strong adaptability and versatility.

• Ability to thrive in a team environment and cultivate positive relationships with colleagues, sponsors, and sites.

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

• Flexibility, a positive attitude, meticulous attention to detail, and strong critical thinking abilities.

• Must possess legal authorization to work in the Czech Republic.

🏝️ Benefits

• Permanent full-time position.

• Flexible work schedule.

• Vacation time.

• Home-based work opportunity.

• Continuous learning and development.

• Attractive opportunities for advancement.

• Accommodations during recruitment and selection for applicants with disabilities, upon request.