Senior Study Start Up Associate

🕒 August 26

🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

✨ Associate

👻 Ghost score 33%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements • Contribute to site start-up and activation activities, taking responsibility for deliverables and working collaboratively • Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications • Coordinate and liaise with internal and external stakeholders to obtain approvals and authorizations for study initiation • Manage and maintain accurate records of regulatory submissions, approvals, and correspondence • Provide guidance and support to study teams on regulatory requirements and study start-up best practices • Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

🎯 Requirements

• Bachelor's degree in life sciences or a related field • Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities • Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements • Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams • Willingness to travel as required (approximately 5%) • Legal right to work in Romania

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways