Wencke Habitzreuther

PROFESSIONAL SUMMARY

Clinical Contracts & Site Negotiation Professional with over 17 years of experience in global clinical trials, including extensive expertise in site contract management, contract negotiations, budget negotiations, and study start-up activities. Proven track record of successfully negotiating Clinical Trial Agreements (CTAs), investigator budgets, and contract amendments while collaborating with cross-functional stakeholders including Legal, Finance, Compliance, Clinical Operations, and global project teams.

Recognized for driving contract execution, mitigating contractual risks, mentoring team members, and supporting the successful delivery of international clinical research programs.

CORE COMPETENCIES

• Clinical Trial Agreements (CTA)
• Contract Negotiation
• Budget Negotiation
• Site Contract Management
• Study Start-Up
• Clinical Operations
• Stakeholder Management
• Risk Assessment
• ICH-GCP
• Cross-functional Collaboration
• Process Improvement
• Mentoring & Training
• Veeva Vault
• Vendor & Site Management

PROFESSIONAL EXPERIENCE

• Independently negotiate Clinical Trial Agreements (CTAs), investigator budgets, and contract amendments for national and international clinical trials.
• Manage the full contract lifecycle from initial contract request through execution and site activation.
• Collaborate closely with clinical trial sites, investigators, Legal, Finance, Clinical Operations, and global study teams.
• Assess contractual and financial risks and develop practical, solution-oriented negotiation strategies.
• Ensure timely study start-up through effective contract and budget management.
• Provide guidance to internal and external stakeholders on contractual, regulatory, and budget-related matters.
• Draft, review, negotiate, and track clinical trial agreements, budgets, and contract amendments.
• Support global clinical trial programs across multiple therapeutic areas and study phases while working within international cross-functional teams.
• Mentor and onboard new team members and contribute to process improvements and knowledge-sharing initiatives.
• Maintain and ensure quality control of contract-related documentation and data within electronic systems and databases.
• Successfully negotiate complex contractual and budget agreements with hospitals, academic medical centers, and investigative sites.
• Build and maintain strong relationships with internal and external stakeholders to support efficient study start-up and successful clinical trial execution.

• Conducted contract and budget negotiations with clinical trial sites across multiple therapeutic areas and study phases.
• Prepared, reviewed, negotiated, and finalized Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), and contract amendments.
• Collaborated with investigators, study coordinators, Legal, Finance, and Clinical Operations teams to support efficient study start-up activities.
• Managed contract timelines and ensured timely progression of negotiations to support site activation goals.
• Identified and escalated contractual and budget-related issues while supporting resolution through collaboration with internal stakeholders.
• Maintained accurate contract documentation and ensured compliance with sponsor requirements, company SOPs, and applicable regulations.
• Supported budget development and negotiation processes with hospitals, academic institutions, and investigative sites.
• Worked within global cross-functional teams to facilitate study start-up and contract execution activities.
• Contributed to process improvements and best practice initiatives to enhance operational efficiency.
• Built strong working relationships with internal and external stakeholders to support successful contract negotiations and study delivery.

• Supported international Phase I–IV clinical trials across multiple therapeutic areas throughout the study lifecycle.
• Partnered closely with Global Project Managers and cross-functional study teams to support the successful execution of global clinical trial programs.
• Coordinated study start-up, maintenance, and close-out activities across international studies.
• Served as a key point of contact for investigative sites, sponsors, and internal stakeholders, ensuring effective communication and collaboration.
• Acted as Subject Matter Expert (SME) for the electronic Trial Master File (eTMF), providing guidance, training, and support to colleagues and project teams.
• Maintained oversight of essential clinical trial documentation and ensured compliance with ICH-GCP, sponsor requirements, and applicable regulatory guidelines.
• Supported regulatory submission activities and maintained high-quality study documentation throughout the study lifecycle.
• Contributed to audit and inspection readiness activities through accurate documentation management and compliance oversight.
• Trained and onboarded new team members and supported knowledge-sharing initiatives across teams.
• Developed extensive expertise in clinical trial operations, stakeholder management, study start-up processes, and global clinical research environments.