Director, Clinical Study Start-Up (UK)

Premier Research Group

United Kingdom

On-site

GBP 90,000 - 140,000

Full time

9 hours ago

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Job summary

Premier Research Group in the United Kingdom is seeking a Director, Study Start Up to lead SSU activities across regions. You will oversee SSU performance, manage staffing, drive timelines, and collaborate with global teams to improve efficiency and compliance with ICH/GCP and ISO14155.

This role requires significant experience in clinical trials, regulatory knowledge, and contract familiarity, offering a strategic leadership position in the SSU program.

Qualifications

Bachelor’s degree in a clinical, scientific or health field.
7–9 years in health sciences or clinical trials; pharma experience preferred.
Direct experience in study start up highly preferred.
5–7 years of people management experience.
Expertise in ICH/GCP and ISO14155 and regulatory requirements.
Working knowledge of FDA and European regulatory procedures.
Knowledge of site/institution contracts.

Responsibilities

Provide oversight for SSU performance within the assigned region.
Manage staffing and resources to ensure regional utilization.
Drive SSU teams to meet project timelines.
Collaborate with regional and US SSU management to align goals.
Apply risk management principles to SSU processes.
Ensure SSU processes comply with contractual requirements.

Skills

Study Start Up

Personnel management

ICH/GCP

ISO14155

Regulatory knowledge (FDA/EU)

Contracting

Clinical trials

Education

Bachelor’s degree in clinical/scientific/health field

Job description

This role requires significant experience in clinical trials, regulatory knowledge, and contract familiarity, offering a strategic leadership position in the SSU program.

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