Clinical Study Team Associate

🕒 3 days ago

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Management and oversight of Study Team shared spaces • Trial Master File (TMF) maintenance, compliance, and oversight • Analyze, interpret, and follow up on metrics • Management and oversight of Study Team on Demand (STOD) • Maintain Pfizer registries and systems as required to ensure compliance • Tracking and oversight of study information; follow up with functional lines as needed • Liaising with cross functional study team members: Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems • Provide study level reporting to support management of clinical trial data, clinical trial budget and timelines • Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission • Support engagement of Independent Oversight Committees • Provide support with audit and inspection readiness activities • Assist with oversight and tracking of Clinical Trial Budget spend • Provide logistical and operational support for Investigator Meetings • Coordinate the translation of documents as required • Provide status updates on key tasks and contribute to the Study Team Meetings as an active Study Team member

🎯 Requirements

• 1-3 years exp with BA/BS or 1+ years exp with MA/MBA/MS • Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS) • Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research • Science background • Experienced with clinical trial processes and applicable systems • Ability to work independently but also as part of a larger team with limited support from supervisor • Ability to multitask and manage multiple competing priorities • Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality • Knowledge of drug development process • Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc. • Good problem solving & decision-making skills: Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems

🏖️ 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