Phase I/II Clinical Study Manager

Adecco Portugal; Welwyn Garden City; On-site; GBP 70,000 - 101,000; Full time

Job summary

Our client, a leading pharmaceutical organisation, is seeking an experienced Study Manager to join their Clinical Operations team in Welwyn Garden City. This 12‑month contract role focuses on coordinating early‑phase clinical studies, ensuring regulatory compliance and timely delivery of innovative research.

The successful candidate will manage study timelines, collaborate with cross‑functional teams and external partners, and support start‑up activities, feasibility assessments, and TMF

Qualifications

• Degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline.
• Experience managing or coordinating clinical studies within a pharmaceutical, biotechnology, or CRO environment.
• Experience supporting Phase I and/or Phase II clinical trials.
• Strong understanding of ICH‑GCP, clinical research regulations, and study management processes.
• Experience working with cross‑functional teams and external vendors.
• Knowledge of study start‑up activities, feasibility assessments, and site management.
• Excellent project management, communication, and stakeholder management skills.
• Proficiency with clinical trial systems, TMF management, and Microsoft Office applications.

Responsibilities

• Support the planning, execution, and delivery of early‑phase clinical studies, ensuring adherence to regulatory requirements, GCP, and company standards.
• Coordinate study timelines, resources, and operational activities to support successful study delivery.
• Collaborate with cross‑functional stakeholders, including Clinical Operations, Data Management, Regulatory Affairs, and external partners.
• Support country and site feasibility assessments, study start‑up activities, and participant recruitment efforts.
• Oversee study documentation and systems, including informed consent forms, communication plans, monitoring plans, and Trial Master Files (TMF).
• Support the selection, management, and oversight of vendors and third‑party suppliers to ensure quality and timely delivery of services.
• Identify, assess, and mitigate study risks while maintaining study action and decision logs.
• Contribute to process improvements and operational excellence initiatives across Clinical Operations.

Skills

Clinical study coordination

Cross‑functional collaboration

Vendor management

TMF management

MS Office

Education

Life Sciences degree

Tools

MS Office

Job description

Our client, a leading pharmaceutical organisation, is seeking an experienced Study Manager to join their Clinical Operations team in Welwyn Garden City. This 12‑month contract role focuses on coordinating early‑phase clinical studies, ensuring regulatory compliance and timely delivery of innovative research.

The successful candidate will manage study timelines, collaborate with cross‑functional teams and external partners, and support start‑up activities, feasibility assessments, and TMF