Global Study Lead

2 weeks ago

Cardiff, United Kingdom Northreach Full time

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector.
Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.
About the Opportunity: We are excited to announce a new opportunity within our expanding Clinical Team for a Global Study Lead .
In this role, you will provide oversight and management of Phase I–III clinical studies, ensuring they are conducted to the highest corporate and regulatory standards.
Key Responsibilities: Oversee the setup and management of fully outsourced clinical studies, ensuring all activities are conducted in line with corporate and regulatory standards.
This includes clinical conduct, drug supply, regulatory submissions, data management, and statistical activities.
Manage clinical budgets and timelines, ensuring forecasts are achieved and deliverables are met.
Provide input into clinical protocols as an active member of the study team.
Lead the development and authorship of key study documents in collaboration with cross-functional teams.
Review, interpret, and analyse clinical data alongside the study team.
Prepare and deliver accurate, timely reports on clinical trial status to senior leadership (monthly, quarterly, or as needed).
Represent the Clinical Team in project team meetings and provide strategic input.
Essential Requirements: Significant experience in Clinical Operations, including the oversight of fully outsourced clinical trials.
Proven global experience in Phase II clinical trials.
Demonstrated ability to manage complex projects with multiple priorities.
Strong working knowledge of GCP/ICH guidelines.
Desirable Requirements: Bachelor's degree in a relevant field (e.g., Biological Sciences, Psychology, Life Sciences) or equivalent professional experience.
Experience conducting studies under an IND (Investigational New Drug).
Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age.
We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI.
We strive to create a welcoming and inclusive environment for all employees.

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