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Experienced Study/Trial Manager

4 months ago


Welwyn Garden City, United Kingdom PHARMExcel Full time

We are seeking a dynamic senior Study/Trial Manager (CSPM) to lead our clinical trials with precision and expertise for a period of 6 months.



Learn more about the general tasks related to this opportunity below, as well as required skills.

As a senior member of our clinical operations team, you will be responsible and accountable for the operational delivery of our clinical studies, as well as ensuring compliance and adherence to timelines, budgets, and regulatory standards. You will be a self -starter, with excellent project management skills, whose drive and leadership will be instrumental in delivering our research initiatives


Key Responsibilities:

·        Lead the planning, initiation, and execution of complex clinical trials from inception to completion.

·        Develop and manage comprehensive study timelines, budgets, and resources.

·        Ensure strict compliance with regulatory requirements, GCP, and ICH guidelines.

·        Lead cross-functional teams, including CRAs, data managers, biostatisticians, and other key stakeholders.

·        Monitor study progress, identifying and resolving issues to maintain study integrity and data quality.

·        Maintain regular communication with senior management, providing detailed reports and updates on study status.

·        Vendor Management including sourcing, compliance, and collaboration

·        Prepare, review, and approve study-related documentation, including protocols, informed consent forms, work instructions and regulatory submissions.

·        Act as an SME to the wider clinical team and support senior clinical management team in developing new processes

·        

·        Qualifications:

·        Bachelor's degree in a related field; advanced degree (e.g., MSc, PhD, MD) preferred.

·        Minimum of 5-7 years of experience in clinical trial management.

·        In-depth knowledge of GCP, FDA regulations, and ICH guidelines.

·        Demonstrated ability to deliver multiple, complex studies simultaneously.

·        Exceptional organisational and project management skills.

·        Strong leadership and team management capabilities.

·        Excellent communication and interpersonal skills.

·        Ability to thrive and adapt in a fast-paced, collaborative environment.


What We Offer:

Competitive salary and comprehensive benefits package.

Opportunities to work on innovative/complex research projects.

A supportive, inclusive, and collaborative work environment.

Professional development and career advancement opportunities.


How to Apply: If you are a seasoned professional with a passion for clinical research and a drive for excellence, we invite you to apply. Please submit your CV and a cover letter detailing your relevant experience and why you are the ideal candidate for this role to Dani Harrison, Head of People and Culture dani.harrison@pharmexcel-cro.com by 28th June 2024.


Join PHARMExcel and make a significant impact in the world of clinical research.



PHARMExcel is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.