Regulatory Affairs Associate Director Clinical Trials
4 days ago
About Simbec-Orion
We are a full-service Contract Research Organization (CRO), delivering high-quality studies from first in man through to Phase III. Our focus is on providing tailormade and scalable solutions, adapting our delivery style, communications, and operations to suit the demands of each project.
About the Role
We are seeking an experienced Regulatory Affairs Associate Director Clinical Trials to join our Medical-Clinical Pharmacology team. This role offers a unique opportunity to work with a dynamic and responsive organization, delivering high-quality clinical trials and advancing medicine.
Key Responsibilities
- Ensure Regulatory Compliance: Oversee the conduct of clinical trials, ensuring compliance with ICH-GCP, MHRA Phase I accreditation requirements, and The Independent Health Care (Wales) Regulations 2011.
- Develop Key Trial Documents: Assess and develop key trial documents and reports, including study protocols, risk management plans, and safety reports, to ensure high-quality delivery.
- Manage Participant Safety: Perform screening, ongoing monitoring, and post-study clinical examinations, managing participant safety and medical emergencies.
- Line Management and Leadership: Provide leadership support and guidance to the Research Physicians and Heads of Departments, deputizing for the Senior Medical Director as required.
Requirements and Qualifications
- Mandatory Skills and Qualifications: GMC registration, post-graduate qualification in Clinical Pharmacology/Pharmaceutical Medicine, experience in conducting clinical trials in a Clinical Pharmacology Unit, and significant experience as a Principal Investigator of FiH studies.
- Deseirable Skills and Qualifications: Valid Advanced Life Support certificate, previous Bio-Tech/Pharma experience, and experience in leading cross-functional project/clinical teams.
Salary and Benefits
The estimated salary range for this position is £100,000 - £130,000 per annum, depending on experience. We offer a comprehensive benefits package, including generous annual leave, flexible working hours, and professional development opportunities.
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