Heads, a global CRO, is seeking a Contracts Manager based in Greece.

This is a full-time job.

Job overview:

To oversee the development, negotiation, and management of contract with investigative sites including Clinical Trial Agreements (CTAs) ensuring all entered agreements are in compliance with regulatory requirements and organizational policies, facilitating clear communication and collaboration to address site-specific needs, resolving disputes, and enhancing the overall efficiency of the contracting process.

Main responsibilities:

Contract Negotiation

• Create, review, and negotiate Clinical Trial Agreements (CTAs) with investigative sites, ensuring that all terms are comprehensive, clear, and aligned with organizational policies, regulatory requirements, and sponsor guideline.
• Actively seek and incorporate feedback from Regulatory, Clinical Operations, and Project Management teams during the process to ensure that all perspectives are considered.
• Manage the review process for any amendments or modifications to existing CTAs, ensuring that changes are documented, communicated, and agreed upon by all relevant parties.
• Serve as a mediator in resolving contractual disputes, to find amicable solutions that satisfy both the organization and the investigative sites.

Contract Preparation & Budget Management

• Coordinate with the client for approval on the Master Payment Scheme (MPS), if required.
• Collaborate with Finance and Project Management teams to develop and finalize budgets for site contracts.
• Communicate with sites to gather feedback on the budget's adequacy in covering their operational needs and advise suitably.
• Work with sites to incorporate any site-specific needs or concerns into the contract template, tailoring the agreements to the unique circumstances of each site while adhering to organizational policies.
• Collaborate with Regulatory, Finance and Clinical Operations teams to review and finalize contract templates, ensuring they reflect the negotiated terms, payment terms accurately.
• Oversee site payments to ensure compliance with contractual agreements and prevent delays.

Stakeholder Management & Communication

• Act as the primary point of contact for investigators and site staff regarding all contract related inquiries, ensuring that they receive timely and accurate information.
• Offer support to site personnel by addressing their queries related to contract terms, payment schedules, and compliance requirements.
• Collaborate closely with Regulatory, Project Management, and Clinical Operations teams to ensure alignment on contractual terms, timelines, and deliverable.
• Provide regular progress reports, updates to senior management and other stakeholders on the performance of contracting processes, negotiation outcomes, cost management, contract statuses, and highlighting any potential issues that may arise.
• Maintain detailed records of all contracts and amendments for audit readiness.

Policies, Processes and Procedures

• Implement approved policies, processes, procedures and maintain awareness of changes in regulations and industry standards that may impact contract terms and processes.
• Monitor day-to-day activities to ensure all contracts comply with applicable regulatory requirements, including ICH-GCP guidelines and local, regional, and international laws.
• Share insights and best practices through trainings on contract management (including country wise regulatory requirements) with own and other teams, if required to enhance overall organizational knowledge and improve future contract processes.
• Comply with the company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection.

Job Requirements:

• Bachelor’s degree in health, law, business administration, life sciences or science related field
• Minimum of 2 years of experience in contract management, negotiation, or a related role.
• Knowledge of clinical trial processes, regulatory requirements, and ICH-GCP guidelines
• Budget Management
• Reporting
• Project management
• Contract preparation
• Process Improvement
• Communication
• Detail orientation
• Collaboration
• Negotiation
• Stakeholder Management
• Excellent command of English both oral and written

Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment.

Competitive remuneration package comes on top.

In Heads we consider Data Protection an integral part of our operational business principles and are committed to respecting your privacy. For information on how we process your personal data please visit our Privacy Notice to Candidates: https://heads-research.com/canditates-privacy-notice/