JOB DESCRIPTION

Our team is expanding, and we are looking to recruit a Contract Specialist or Senior Contract Specialist for our growing FSP environment.
The Contract Specialist in the FSP group is responsible for managing and overseeing contractual aspects of clinical trials conducted by the FSP on behalf of its clients. This role involves negotiating, drafting, and finalizing high-value and complex contracts, ensuring compliance with relevant regulations, and maintaining effective communication with internal and external stakeholders. The Senior Contract Specialist also provides mentorship and guidance to junior contract specialists.

QUALIFICATIONS:

• Bachelor’s degree in a relevant field (e.g., Law, Business Administration, Life Sciences).
• Extensive experience in contract management or negotiation within the pharmaceutical, clinical research, or related industry.
• Strong knowledge of contractual regulations and guidelines governing clinical trials.
• Excellent organizational and project management skills.
• Effective communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams.
• Attention to detail and the ability to manage multiple projects and deadlines.
• Proficiency in both written and spoken English; additional language skills may be beneficial depending on the location.

PREFERRED QUALIFICATIONS:

• Advanced degree or certification in contract management or a related field.
• Experience in an FSP environment, providing services to multiple clients.
• Familiarity with electronic contract management systems and databases.
• Previous experience in a senior or leadership role within contract management.

• 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.