Early-Phase Study Manager, Clinical Operations

Adecco Portugal; Welwyn Hatfield; Presencial; GBP 70 000 - 101 000; Tempo integral

Resumo da oferta

Adecco is seeking a Study Manager for an early-phase clinical operations role in Welwyn Garden City. The contract covers planning, execution, and delivery of studies, with emphasis on GCP compliance and TMF management.

The role requires coordinating cross-functional teams, managing vendors, and supporting site feasibility and recruitment, contributing to operational excellence within a leading pharmaceutical organisation.

Qualificações

• Degree in Life Sciences, Pharmacy, Nursing, or related field.
• Experience coordinating or managing clinical studies in pharma/biotech/CRO.
• Experience supporting Phase I/II trials.
• Strong knowledge of ICH-GCP and study management processes.
• Experience with cross-functional teams and external vendors.
• Familiarity with startup activities, feasibility, and site management.
• Excellent project management and stakeholder skills.
• Proficiency in TMF management and trial systems.

Responsabilidades

• Support planning, execution, and delivery of early-phase studies per regulatory standards.
• Coordinate timelines, resources, and operational activities for study delivery.
• Collaborate with Clinical Operations, Data Management, Regulatory Affairs and external partners.
• Support country/site feasibility, start-up activities, and participant recruitment.
• Oversee TMF, informed consent documents, and communication plans.
• Oversee vendor selection, management, and oversight.
• Identify and mitigate study risks and maintain action logs.
• Contribute to process improvements within Clinical Operations.

Conhecimentos

Clinical trial management

GCP & ICH

Regulatory compliance

Vendor management

Cross-functional collaboration

Study start-up / feasibility

TMF systems experience

Advanced MS Office

Formação académica

Bachelor's degree in Life Sciences

Ferramentas

CTMS

TMF management tools

Microsoft Office

Descrição da oferta de emprego

Adecco is seeking a Study Manager for an early-phase clinical operations role in Welwyn Garden City. The contract covers planning, execution, and delivery of studies, with emphasis on GCP compliance and TMF management.

The role requires coordinating cross-functional teams, managing vendors, and supporting site feasibility and recruitment, contributing to operational excellence within a leading pharmaceutical organisation.