Study Contract Manager
AstraZeneca · Province de Taïwan
Job description
About the role
The Study Contract Manager will oversee the end‑to‑end delivery of study services across the clinical research portfolio, ensuring consistency, compliance and operational excellence. This role acts as the central point of contact for document management and supports teams throughout the study lifecycle.
Key responsibilities
- Coordinate lifecycle management, enhancements and business continuity for study delivery processes, systems and reporting.
- Develop, implement and improve reporting tools, metrics and analytical processes.
- Lead centrally managed services such as document management, clinical trial transparency and system training.
- Serve as the primary contact for document management from production to regulatory archiving.
- Collaborate with internal stakeholders and external partners to ensure seamless study administration and regulatory compliance.
- Facilitate knowledge sharing, best‑practice dissemination and training on study systems and procedures.
- Act as subject‑matter expert for risk, contingency and change management, resolving operational issues.
- Monitor external trends, regulatory requirements and emerging technologies to drive process improvements.
- Manage study materials, equipment and controlled documents to maintain audit readiness.
- Support audit and inspection activities and advise project teams on effective study methodologies.
Required profile
- University degree in biological science, health‑related field, nursing or equivalent experience.
- Significant experience in the pharmaceutical industry within clinical study delivery or development.
- Strong knowledge of clinical and pharmaceutical drug development processes and regulations (ICH, GCP).
- Proven ability to work collaboratively and independently, with excellent communication and negotiation skills.
- Demonstrated leadership, priority‑setting and project management capabilities.
Required skills
- Clinical trial management systems
- Document management and e‑TMF tools
- Regulatory compliance (ICH, GCP)
- Risk and change management
- Reporting and analytical tools
What we offer
- Opportunity to shape study delivery processes across a global portfolio.
- Collaborative environment with cross‑functional teams.
- Access to cutting‑edge technologies and continuous improvement initiatives.
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AstraZeneca
Province de Taïwan