Position Overview:
A Top 10 Pharmaceutical company is seeking a highly motivated and experienced Associate Director, Clinical Outsourcing and Contracts Specialist to join their dynamic team. In this role, you will play a crucial part in managing the clinical outsourcing activities and contracts related to our clinical trials, directly supporting the clinical development team. You will collaborate closely with internal stakeholders, external vendors, and legal teams to ensure efficient and effective outsourcing processes, contract negotiation, and compliance. This is a very high visibility role as it will be supporting our large scale, late stage program.
Responsibilities:
- Oversee the end-to-end process of clinical outsourcing, including vendor identification, selection, and qualification.
- Develop and negotiate contracts with external vendors, ensuring compliance with company policies, regulations, and industry standards.
- Collaborate with cross-functional teams to identify outsourcing needs, draft Request for Proposal (RFP) documents, and evaluate vendor proposals.
- Manage vendor relationships, performance metrics, and issue resolution throughout the duration of contracts.
- Conduct risk assessments and implement mitigation strategies to ensure quality, cost-effectiveness, and timely delivery of outsourced activities.
- Stay up-to-date with relevant industry trends, regulations, and best practices related to clinical outsourcing and contracts management.
- Maintain accurate and complete documentation of all outsourcing activities and contracts.
Qualifications:
- Bachelor's degree in life sciences, business administration, or a related field. Advanced degree is preferred.
- Proven experience in clinical outsourcing and contracts management within the pharmaceutical or biotechnology industry.
- Strong knowledge of global regulations and guidelines related to clinical trials and vendor management (e.g., ICH-GCP, FDA, EMA).
- Demonstrated ability to negotiate and draft complex contracts with external vendors.
- Excellent organizational skills with the ability to handle multiple tasks and prioritize effectively.
- Strong communication and interpersonal skills to effectively collaborate with stakeholders at all levels.
- Detail-oriented mindset with a focus on accuracy and compliance.
- Proficiency in using contract management software and Microsoft Office Suite.
We are an equal opportunity employer and value diversity in our workforce. We encourage applications from individuals of all backgrounds and experiences.
