Study Manager

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

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Clinical trial management

GCP & ICH

Regulatory compliance

Vendor management

Cross-functional collaboration

Study start-up / feasibility

TMF systems experience

Advanced MS Office

Education

Bachelor's degree in Life Sciences

Tools

CTMS

TMF management tools

Microsoft Office

Job description

Study Manager

Location: Welwyn Garden City

Contract Length: 12 months

Daily Rate: £377.54 - £550.00 (insideIR35

Our client, a leading pharmaceutical organisation, is seeking an experienced Study Manager to join their Clinical Operations team in Welwyn Garden City. This is an excellent opportunity for a clinical research professional with experience managing early-phase clinical trials to contribute to the successful delivery of innovative studies that support the development of new treatments.

Key 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.

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.

Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.

We use generative AI tools to support our candidate screening process. This helps us ensure a fair, consistent, and efficient experience for all applicants. Rest assured, all final decisions are made by our hiring team, and your application will be reviewed with care and attention.