Study Specialist II – Global Study Operations

Study Specialist II – Global Study Operations (12 Month Contract)

We’re currently supporting an exciting opportunity with a leading rare disease biotechnology company for a Study Specialist II to join their Global Study Operations team.

This role will play a key part in supporting the delivery of Phase I-IV and post-approval clinical studies, working closely with Study Managers, CROs, vendors, and cross-functional stakeholders to ensure high-quality study execution.

Key Responsibilities

• Support study planning, execution, and operational delivery activities.
• Contribute to site feasibility, site management, and investigator support.
• Oversee essential study documentation and Trial Master File (TMF) management.
• Support vendor oversight and management, including CROs and specialist vendors.
• Coordinate regulatory document collection and study start-up activities.
• Assist with investigator meetings, site training materials, and study communications.
• Manage study tracking, payments, document workflows, and operational processes.
• Support risk identification and mitigation activities across assigned studies.
• Act as a key operational partner within cross-functional study execution teams.

What We’re Looking For

• Bachelor’s degree in Life Sciences, Health Sciences, Nursing, or a related field (or equivalent industry experience).
• Experience supporting global clinical trials within a pharmaceutical, biotechnology, or CRO environment.
• Knowledge of clinical study operations, site management, and study execution.
• Experience working with external vendors such as CROs, central labs, or imaging providers.
• Strong understanding of GCP, compliance, and clinical trial processes.
• Excellent organisational, communication, and stakeholder management skills.

Why Apply?

• Join a company dedicated to developing therapies for patients with rare genetic diseases.
• Work within a highly collaborative global clinical operations environment.
• Gain exposure across study management, vendor oversight, and global clinical trial delivery.
• Opportunity to contribute to studies that have a meaningful impact on patients’ lives.

Interested? Apply now or message me directly for more information.

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