Senior Study Specialist, Global Study Operations

Biomarin; City of Westminster; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading biotechnology firm located in the UK seeks a Senior Study Specialist to manage site monitoring, vendor oversight, and critical study-related tasks. The ideal candidate will demonstrate independence in executing complex assignments and have a strong background in biotech or pharmaceuticals, ensuring participant safety and data integrity. Responsibilities include developing documentation, overseeing essential study activities, and training. This role is vital for advancing innovative therapeutics targeting rare genetic diseases in a dynamic environment.

Qualifications

• Experience in a biotechnology or pharmaceutical company is preferred.
• Oversight of external vendors including SOW, budgets, POs, and invoice management.

Responsibilities

• Develop study specific documentation, as delegated by the Study Manager.
• Contribute to the oversight of country and site feasibility assessment.
• Oversight of essential documents for study life‑cycle management.
• Oversee and manage essential documents in the Trial Master File (TMF).

Skills

Agility and Proactivity

Leadership

Communication and Collaboration

Education

BA/BS or higher in nursing, life or health sciences

Job description

The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).

Core Competencies

• Agility and Proactivity
• Leadership
• Communication and Collaboration

Technical Competencies

• Study Management and Execution
• Compliance and Quality
• Drug Development and Study Design
• Product and Therapeutic Area Knowledge

Responsibilities

• Develop study specific documentation, as delegated by the Study Manager
• Contribute to the oversight of country and site feasibility assessment and site selection.
• Oversight of CRO for IRB/EC related submission/approval activities
• Oversight of essential documents for study life‑cycle management
• Develop/Oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely study entry and updates to ClinicalTrials.gov
• Facilitate Screening Authorization Forms sign off and oversee tracking, where applicable
• Process documents for signature in DocuSign
• Oversight of Clinical Trial Insurance
• Attend Global Study Operations team, vendor, and/or Cross‑Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.
• Oversee and manage essential documents in the Trial Master File (TMF)
• Contribute to Global Study Operations risks identification and mitigations.
• Provide support and administrative assistance with internal and external meetings

Qualifications

• BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
• Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging, etc.)

About BioMarin

From research and discovery to post‑market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first‑in‑class and best‑in‑class therapeutics that provide meaningful advances to patients who live with genetic diseases.

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life‑threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care, and providing personalized support and services globally.

The BioMarin Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high‑quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross‑functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.