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CONTRACT MANAGMENT SPECIALIST & REGULATORY

Descripción de la oferta de empleo

Contract Management Specialist & RegulatoryLocation: RemoteType: Full-time / PermanentRole 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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Detalles de la oferta

Empresa
  • Oxford Global Resources
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 14/12/2024
Fecha de expiración
  • 14/03/2025
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