Join a cutting-edge pharmaceutical team where your precision and passion for pharma will help shape the future of life-saving medicines!
Proclinical is seeking a Global Study Asset Manager for a 6-month contract role. In this position, you will lead the operational delivery of one or more molecule assets or global clinical studies. This role requires close collaboration with cross-functional teams and external partners to ensure high-quality and timely study execution.
Responsibilities:
- Coordinate study management activities in 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 third-party vendor setup and performance.
- 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 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.
If you are having difficulty in applying or if you have any questions, please contact Dean Fisher at d.fisher@proclinical.com.
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Global Study Asset Manager in Welwyn employer: ProClinical
Join a globally recognised biopharmaceutical organisation that prioritises innovation and collaboration in the field of protein science and biologic drug development. With a strong commitment to employee growth, you will have access to continuous learning opportunities and be part of a supportive team dedicated to delivering life-changing therapies. Located in a vibrant area, this role not only offers meaningful work but also a dynamic work culture that values your contributions and fosters professional development.
