Site Budget and Contract Lead

Job not on LinkedIn

🔥 4 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

Where this job comes from

Posted on Innovaderm Research Inc.'s careers page, not through a job board

First seen by Remote Rocketship 4 minutes ago

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Logo of Innovaderm Research Inc.

Innovaderm Research Inc.

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Lead development of investigator budgets and contract proposals • Serve as the main point of contact for budget and contract negotiations with investigator sites and Sponsors • Develop draft clinical budgets for new studies • Develop and maintain country-specific, sponsor-approved minimum and maximum budget grids • Develop project-specific Clinical Trial Agreement templates customized to country and sponsor requirements • Facilitate negotiation and signature of site budgets and contracts with investigators, Legal Affairs, and Sponsors as appropriate • 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 • Support Regulatory Affairs in reviewing informed consent templates so subject compensation text aligns with approved study budgets • Facilitate site negotiations and communications through contractors, sub-CROs, or CRAs when required • Provide oversight to contractors, Sub-CROs, and Innovaderm/Indero 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 • Communicate with sites in local languages where possible • Maintain training and compliance with internal processes and SOPs • Participate in departmental projects and provide site budget and contracting expertise • Mentor junior team members as a subject matter expert • Support the Manager, Site Selection and Contracting in delivering high-quality project results

🎯 Requirements

• Bachelor's degree in a field relevant to clinical research or equivalent experience • Minimum of 4 years’ experience in clinical research in site budget/contract negotiation in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in site selection, study start-up activities and/or work 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) • Ability to work under pressure and with tight timelines • Quick learner, adaptable and versatile • 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 the Czech Republic

🏖️ Benefits

• 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

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