Senior Contracts and Budget Associate

Organization: Precision Medicine Group

Location: South Korea

Position Summary:

Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents. Will work closely with the Clinical Operations study team and play an administrative role to ensure deliverables are in alignment with defined project timelines and expectations. The Senior Contracts and Budget Associate will be instrumental in ensuring that all contracts are compliant with regulatory requirements while also aligning with the strategic goals of the organization. This role requires a keen attention to detail and the ability to manage multiple priorities effectively.

Essential functions of the job include but are not limited to:

• Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), vendor contracts and site budgets.
• Lead interactions with the North American and European internal study teams, as applicable, ensuring seamless communication and collaboration.
• Lead interactions regarding the various agreements with the Site(s), focusing on establishing strong relationships with external partners.
• Lead interactions regarding assigned agreements with the Sponsor(s), facilitating negotiations that reflect the organization’s priorities.
• Work with supervisor and various internal/external stakeholders to resolve contractual issues, employing problem-solving skills to navigate complex situations.
• Ensure adhered to company policies, procedures, and contracting standards, maintaining high ethical standards in all dealings.
• Update relevant study team members and sponsors regarding the status of contract negotiations and execution, ensuring transparency throughout the process.
• Coordinate execution of the agreements, guaranteeing that all parties fulfill their obligations in a timely manner.
• Support the maintenance of contract files and databases, including email and document archiving, to uphold organizational efficiency.
• Other duties as assigned, which may include providing training to junior staff on contract management processes.

Key Performance Indicators (KPIs) for this role include:

• Timely preparation and negotiation of agreements, ensuring seamless communication and collaboration with internal and external stakeholders.
• Effective management of multiple priorities, ensuring that all contracts are compliant with regulatory requirements and align with the organization’s strategic goals.
• Strong relationships with external partners, including sites and sponsors, fostering a collaborative environment that supports the organization’s priorities.
• Efficient resolution of contractual issues, employing problem-solving skills to navigate complex situations and ensure timely execution of agreements.
• Adherence to company policies, procedures, and contracting standards, maintaining high ethical standards in all dealings and ensuring transparency throughout the process.

Qualifications:

Minimum Required:

• Bachelor’s degree, or equivalent contract management experience preferably in a clinical research or similar industry setting. A strong academic background in law, business administration, or a related field can be advantageous.

Other Required:
• 3 years of relevant experience drafting, reviewing and negotiating agreements related to clinical research, i.e. Non-Disclosure Agreements, Clinical Trial Agreements, etc. as well as management, control and tracking of the contract process. Demonstrated success in navigating complex contract negotiations will be particularly valuable.
• Experience in contract research, life science, biotech or pharmaceutical industry is preferred. Familiarity with industry trends and regulations will enhance the ability to perform effectively in this role.

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