Clinical Lab Scientist I

Description

This is a first shift position (9:00 AM to 6:00 PM, M-F) for a Clinical Lab Scientist.

Key Requirements

• Bachelor's degree in Life Sciences (BA/BS)
• 1-3 years of experience in a clinical lab setting; histology or IHC experience preferred
• Demonstrates strong teamwork and adaptability, combining a willingness to follow direction with the self-motivation needed to deliver consistent results

Preferred

• Histotechnologist certification (HT or HTL)

The Opportunity

• Lead clinical and medical research studies
• Analyze clinical trial data and publish findings
• Ensure compliance with medical research regulations
• Collaborate with healthcare professionals and research teams
• Support drug and therapy development efforts

Who You Are

• 1-3 years of experience
• Strong problem-solving skills
• Excellent communication abilities
• Knowledge of industry best practices

Preferred (Optional)

• Experience in clinical trials preferred

Opportunity Details

• Lead the development and oversight for clinical trial submissions, amendments and regulatory coordination, managing packages, responding to queries, ensuring document maintenance, and supporting amendments throughout the trial lifecycle
• Strategically manage site documentation and compliance, overseeing document collection/validation, coordination of related processes, and local vendor management (excluding CROs) if needed
• Maintain up-to-date knowledge of country-specific regulations, including those for medicinal products, medical devices, and IVDRs

Qualifications

• Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent
• Postgraduate degree or master's degree highly desirable
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments
• Experience managing vendor/CRO relationships

Skills & Competencies

• Excellent communication and interpersonal skills
• Strong organizational, analytical, and problem-solving capabilities
• Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.)
• Collaborative and adaptable mindset with attention to detail
• Ability to lead through complexity and ambiguity, especially in matrixed and global teams
• Fluency in written and spoken English is mandatory
• Fluency in written and spoken language(s) of the host country is mandatory