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Site Budget and Contract Lead
Innovaderm Research Inc.. Lead development of investigator budget and contract proposals .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in budget and contract negotiation within clinical research, with a strong focus on managing relationships with sponsors and clinical sites. Proficient in developing clinical budgets and contract templates while ensuring compliance with local regulations and internal processes.
Highest-signal resume keywords
Clinical Research Budget NegotiationContract ManagementBilingual Communication SkillsProject ManagementRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Budget DevelopmentContract NegotiationSite SelectionStudy Start-Up ActivitiesMicrosoft Office SuiteClinical Trial Agreement TemplatesBudget Tracking SystemsClinical Research RegulationsDermatological Clinical ResearchRheumatological Clinical Research
Soft Skills
Organizational SkillsAttention to DetailCritical ThinkingAdaptabilityTeam Collaboration
Tools & Technologies
CTMS
Industry Keywords
BiotechnologyPharmaceuticalCROEU RegulationsClinical Research Sites
About the role
Key responsibilities & impact- Lead development of investigator budget and contract proposals
- Act as the main point of contact for budget and contract negotiations with investigator sites and Sponsors
- Manage project activities related to contracts and budgets and interact with clients as needed
- Develop and maintain relationships with clinical research sites and Sponsors
- Develop draft clinical budgets for new studies
- Develop and maintain country-specific, sponsor-approved minimum and maximum budget grids for site negotiations
- Develop project-specific Clinical Trial Agreement templates customized to country and sponsor requirements
- Facilitate negotiation and signature of site budgets and contracts with investigators, collaborating with Legal Affairs and Sponsors as appropriate
- Adapt contracting processes to country-specific requirements
- Manage contract and budget amendments during trials
- Update tracking systems to facilitate site payments
- Attend internal and client project team meetings as necessary
- Collaborate with Project Management, Regulatory Affairs, Legal Affairs, Finance, CTMS, and other internal teams
- Ensure fully executed contract deliverables are completed on time according to study timelines
- Support Regulatory Affairs with informed consent form master templates to align subject compensation text with approved study budgets
- Facilitate site negotiations and communications through contractors, sub-CROs, or CRAs when required by site location or language
- Provide oversight to contractors, Sub-CROs, and Innovaderm SBCLs across multiple countries
- Act as functional lead for contract management in global studies and main Sponsor point of contact for contract management matters
- Ensure total study budgets remain within scope and escalate out-of-scope budget requests to Sponsors
- Help communicate with sites in local languages when possible
- Maintain training and compliance with internal processes and SOPs
- Participate in departmental projects involving site selection, contracting, and other groups
- Serve as subject matter expert and mentor junior team members on budget and contract negotiations
- Support the Manager, Site Selection and Contracting, to ensure project goals, scope, requirements, and quality results are achieved
Requirements
What you’ll need- Bachelor's degree in a field relevant to clinical research or equivalent experience
- Minimum of 7 years’ experience in clinical research in site budget/contract negotiation in the biotechnology, pharmaceutical, or CRO industry
- Significant and relevant experience in site selection, study start-up activities and/or working closely with sites or in a site environment
- Minimum 2 years’ experience in a similar contract lead role in the biotechnology, pharmaceutical, or CRO industry
- Excellent English written and spoken skills
- Bilingual with Spanish, German or Polish languages; fluency in 2+ EU languages is an asset
- Strong ability to carry out different projects simultaneously, organize work effectively, and work under pressure in accordance with deadlines
- Excellent knowledge of the Microsoft Office suite, including Word, Excel, PowerPoint, and Outlook
- Prior clinical research experience in EU countries, and knowledge of local regulations and processes is an asset
- Experience of dermatological and rheumatological clinical research is an asset
- Ability to work under pressure and with tight timelines
- Quick learner, good adaptability and versatility
- Ability to work in a team environment and establish good relationships with colleagues, sponsors, and sites
- Organized and able to juggle competing priorities in a fast-paced and evolving environment
- Flexibility, positive attitude, superior attention to detail, and critical thinking skills
- Legal authorization to work in the Czech Republic
Benefits
Comp & perks- Permanent full-time position
- Flexible schedule
- Vacation
- Home-based position
- Ongoing learning and development
- Attractive advancement opportunities
- Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request