Contract Managment Specialist

hace 3 días

Madrid, España Oxford Global Resources A tiempo completo
Contract Management Specialist & Regulatory
Location: Remote
Type: Full-time / Permanent
Role Overview:
We are seeking a highly skilled and motivated Contract Management Specialist & Regulatory Expert to join our team, specializing in observational, late-phase, and real-world evidence (rWE) studies. This role involves managing regulatory processes and contracts across global clinical projects while ensuring compliance with industry standards and timelines.
Key Responsibilities:
- Contract Management:
- Draft, review, and negotiate contracts, including Clinical Trial Agreements (CTAs), confidentiality agreements, and vendor agreements.
- Ensure timely execution of contracts, aligning with project timelines and stakeholder requirements.
- Act as the primary point of contact for contract-related inquiries and escalations.
- Regulatory Compliance:
- Oversee regulatory submissions for observational and late-phase studies, ensuring adherence to local and international guidelines.
- Collaborate with cross-functional teams to support the preparation and submission of regulatory documents.
- Maintain up-to-date knowledge of regulatory requirements and industry best practices.
- Collaboration & Coordination:
- Liaise with internal and external stakeholders, including regulatory authorities, ethics committees, and sponsors.
- Support project teams in addressing regulatory and contractual issues.
- Track and report on project status, ensuring compliance with milestones and budgets.
Qualifications & Experience:
- Bachelor’s degree in life sciences, law, or a related field. A Master’s degree is a plus.
- Minimum 3 years of experience in contract management and regulatory affairs, preferably in observational or late-phase clinical studies.
- Strong understanding of ICH-GCP, GDPR, and other relevant regulations.
- Proven experience working with international stakeholders and regulatory authorities.
- Excellent organizational skills with the ability to manage multiple projects simultaneously.
- Proficiency in MS Office and contract management tools.
Key Competencies:
- Strong analytical and problem-solving skills.
- Exceptional written and verbal communication in English (additional languages are a plus).
- Ability to work independently and collaboratively in a fast-paced environment.
What We Offer:
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- Competitive salary and benefits package.
Join us to contribute to cutting-edge research that shapes the future of healthcare

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