Contract Specialist / Sr Contract Specialist, FSP - DACH

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Job Description

Our team is expanding, and we are seeking a Contract Specialist or Senior Contract Specialist for our growing FSP environment.

The Contract Specialist in the FSP group manages 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 mentors and guides junior contract specialists.

Key Responsibilities:

1. 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.
2. Ensure contracts comply with local and international regulations and company policies.
3. Collaborate with internal teams such as legal, clinical operations, regulatory affairs, and finance to ensure alignment and compliance with contractual requirements.
4. Liaise with external stakeholders including clients, sites, and vendors to facilitate contract negotiation and approval processes.
5. Monitor contract negotiations and address any issues or concerns that arise.
6. Maintain accurate records and documentation related to contracts and agreements.
7. Provide guidance and support to project teams on contractual matters throughout the clinical trial lifecycle.
8. Participate in developing and implementing contract management strategies and processes.
9. Ensure timely execution of contracts to meet project timelines and deadlines.
10. Support the resolution of contractual disputes and issues as they occur.
11. Stay updated on changes in regulations and industry standards related to clinical trial contracts.
12. Mentor and guide junior contract specialists, supporting their professional development.
13. Participate in training sessions and workshops to enhance the team\’s contract management skills.

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 across teams.
• Attention to detail and ability to manage multiple projects and deadlines.
• Proficiency in both written and spoken English; additional languages may be beneficial depending on 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 leadership or senior role in contract management.

Required Experience:

Senior IC

Key Skills:

IVR, SOAP, Avaya, Solaris, Cost Accounting Standards, Database Design, Hibernate, ITIL, Weblogic, Express.js, Contracts, ASP

Employment Type: Full-Time

Experience: years

Vacancy: 1

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