Site Budget and Contract Lead

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

📋 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 all project-related activities concerning contracts and budgets.

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

• Prepare preliminary clinical budgets for new research studies.

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

• Develop tailored project-specific Clinical Trial Agreement (CTA) templates according to country and sponsor specifications.

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

• Adjust processes to meet country-specific requirements.

• Oversee contract and budget amendments during clinical trials.

• Refresh 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 various internal teams.

• Ensure timely completion of fully executed contract deliverables according to study timelines.

• Review and assist Regulatory Affairs with informed consent form templates to align subject compensation text with approved study budgets.

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

• Provide oversight to contractors, Sub-CROs, and Innovaderm SBCS across multiple countries.

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

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

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

• Maintain training and compliance with internal processes and SOPs.

• Engage in departmental projects related to site selection, contracting, and initiatives from other groups.

• Serve as a subject matter expert and mentor junior team members on budget and contract negotiations.

• Support the Manager, Site Selection and Contracting in achieving high-quality project outcomes.

⛳️ Requirements

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

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

• Extensive and pertinent experience in site selection, study start-up activities, or close collaboration with sites or in a site environment.

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

• Exceptional English communication skills, both written and spoken.

• Proficiency in Spanish, German, or Polish.

• Fluency in 2 or more EU languages is a plus.

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

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

• Prior clinical research experience in EU countries, along with knowledge of local regulations and procedures, is advantageous.

• Experience in dermatological and rheumatological clinical research is a plus.

• Ability to perform effectively under pressure and within tight timelines.

• Quick learner with strong adaptability and versatility.

• Competent in team collaboration and building positive relationships with colleagues, sponsors, and sites.

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

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

• Legally authorized to work in Poland.

🏝️ Benefits

• Permanent full-time position.

• Paid vacation.

• PPK (Employee Capital Plan).

• Health allowance.

• Home-based position with teleworking allowance.

• Ongoing learning and development opportunities.

• Attractive career advancement prospects.

• Commitment to equitable treatment and equal opportunity.

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