Shape the Future of Life-Saving Medicines
Join a cutting-edge pharmaceutical team where your precision and passion for pharma will help drive the development of essential treatments. This 6-month contract role offers the opportunity to lead the operational delivery of one or more molecule assets or global clinical studies, ensuring high-quality and timely execution through close collaboration with cross-functional teams and external partners.
Core Responsibilities
- Coordinate study management activities in strict compliance with ICH-GCP guidelines and standard operating procedures (SOPs).
- Develop and contribute to essential study documents, including protocols, pharmacy manuals, and trial management plans (TMPs).
- Oversee recruitment forecasting, vendor selection, and the setup and performance management of third-party vendors.
- Manage investigational medicinal product (IMP) supply and shipment logistics.
- Ensure clinical trial insurance is in place and manage the production and distribution of patient and site-facing materials, including translations.
- Define and track key performance indicators (KPIs) to monitor study progress.
- Maintain inspection readiness throughout the entire study lifecycle.
- Collaborate with contract research organizations (CROs) and internal cross-functional teams to ensure quality and efficiency in study delivery.
Key Skills and Requirements
- Relevant experience in clinical operations, with a focus on study management (Phase 3 experience preferred).
- Strong understanding of drug development processes, ICH guidelines, and GCP standards.
- Proven ability to work effectively with CROs and cross-functional stakeholders.
- Skilled in managing complex projects in a fast-paced and dynamic environment.
- A university degree in life sciences or equivalent experience is preferred.
- Strong organizational and problem-solving skills, with a focus on innovation and operational efficiency.