Contract Specialist

• Draft, review, and negotiate high-value and complex contracts related to clinical trials, including Clinical Trial Agreements (CTAs), Confidentiality Agreements (CDAs), and other relevant documents
• Ensure contracts are compliant with local and international regulations and company policies
• Collaborate with internal teams, including legal, clinical operations, regulatory affairs, and finance, to ensure alignment and compliance with contractual requirements
• Liaise with external stakeholders, including clients, sites, and vendors, to facilitate the contract negotiation and approval process
• Monitor the progress of contract negotiations and address any issues or concerns that arise
• Maintain accurate records and documentation related to contracts and agreements
• Provide guidance and support to project teams on contractual matters throughout the lifecycle of clinical trials
• Participate in the development and implementation of contract management strategies and processes
• Ensure timely execution of contracts to meet project timelines and deadlines
• Support the resolution of contractual disputes and issues as they arise
• Stay up-to-date with changes in regulations and industry standards related to clinical trial contracts
• Mentor and provide guidance to junior contract specialists, assisting in their professional development
• Participate in training sessions and workshops to enhance the contract management skills of the team

Contract Specialist managing clinical trial agreements for Thermo Fisher Scientific

Contract Specialist, Senior Contract Specialist

Contract Specialist managing high-value contracts for clinical trials at Thermo Fisher Scientific. Drafting, negotiating, and ensuring compliance in a remote role based in Germany.

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials
• Produces site-specific contracts from country template
• Provides support in submissions for proposed contract and budget for site
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues
• Facilitates the execution of contracts by company signatories
• Maintains contract templates and site specific files and databases
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products

Contract Specialist managing contract processes for clinical trials at Syneos Health

Contract Specialist administering contract management processes for clinical trials at Syneos Health. Engaging in negotiations, contract preparation, and collaboration with various teams and stakeholders.

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Contract Specialist, Senior Contract Specialist

Contract Specialist