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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 clinical budget and contract negotiations, with a strong focus on managing relationships with clinical research sites and sponsors. Proficient in developing and maintaining project-specific Clinical Trial Agreements and adapting processes to meet country-specific requirements.
Highest-signal resume keywords
Clinical Budget NegotiationContract ManagementClinical Trial Agreement DevelopmentBilingual CommunicationProject Management
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 ResearchBudget DevelopmentContract NegotiationSite SelectionRegulatory KnowledgeMicrosoft Office SuiteClinical Trial Agreement TemplatesStudy Start-Up ActivitiesTracking Systems ManagementClinical Research in EU
Soft Skills
Organizational SkillsAdaptabilityAttention to DetailCritical ThinkingTeam Collaboration
Tools & Technologies
CTMS
Industry Keywords
BiotechnologyPharmaceuticalCRODermatological ResearchRheumatological ResearchEU RegulationsSite Environment
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 all project activities related to contracts and budgets
- 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 (CTA) 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 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
- 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
- Review and support Regulatory Affairs on 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 needed
- Provide oversight to contractors, Sub-CROs, and Innovaderm SBCS across multiple countries
- Act as functional lead for contract management in global studies and main sponsor point of contact
- Ensure total study budgets remain within scope and escalate out-of-scope requests to Sponsors
- Aid communication with sites in local languages, if possible
- Maintain training and compliance with internal processes and SOPs
- Participate in departmental projects related to site selection, contracting, and other groups’ initiatives
- Act as subject matter expert and mentor junior team members on budget and contract negotiations
- Support the Manager, Site Selection and Contracting in delivering high-quality project results
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 (Word, Excel, PowerPoint, 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, able to juggle competing priorities, and work in a fast-paced and evolving environment
- Flexibility, positive attitude, superior attention to detail, and critical thinking skills
- Legally authorized to work in Poland
Benefits
Comp & perks- Permanent full-time position
- Vacation
- PPK
- Health allowance
- Home-based position with teleworking allowance
- Ongoing learning and development
- Attractive advancement opportunities
- Equitable treatment and equal opportunity
- Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request