Global Study Asset Manager

Proclinical; Welwyn; On-site; GBP 60,000 - 90,000; Full time

Job summary

Proclinical is seeking a Global Study Asset Manager for a 6-month contract in Welwyn, UK. You will lead the operational delivery of study assets and collaborate with cross-functional teams and external partners to ensure quality and timely study execution.

The role requires knowledge of ICH-GCP, experience with CROs, and strong project management skills in a fast-paced environment; a life sciences degree is preferred.

Qualifications

• Experience in clinical operations with study management focus (Phase 3 preferred).
• Strong knowledge of drug development processes and ICH/GCP standards.
• Proven ability to work with CROs and cross-functional stakeholders.
• Able to manage complex projects in a fast-paced environment.
• University degree in life sciences or equivalent preferred.

Responsibilities

• Coordinate study management activities per ICH-GCP and SOPs.
• Develop essential study documents (protocols, pharmacy manuals, TMPs).
• Oversee recruitment forecasting, vendor selection, and third-party setup.
• Manage IMP supply and shipment logistics.
• Ensure clinical trial insurance and manage materials production/distribution including translations.
• Define and track KPIs to monitor progress.
• Maintain inspection readiness throughout the study lifecycle.
• Collaborate with CROs and internal teams to ensure quality and efficiency.

Skills

Study management

ICH-GCP/GCP

Vendor management

IMP logistics

KPI tracking

Inspection readiness

Cross-functional collaboration

Education

Life sciences degree

Job description

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 [e-mail].