Integrated Study Timeline Manager

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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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

• Lead development, customization, and maintenance of Integrated Study Timelines (IST) for clinical trials • Collaborate with Global Trial Leads and cross-functional team members • Identify key study activities to drive study timeline development • Communicate timeline updates to stakeholders clearly and timely • Manage user access to study timelines • Support process improvement initiatives • Attend study execution team meetings • Coordinate timeline-related discussions • Identify critical path items related to timelines management • Run timeline status reports and post updated timelines regularly • Support Microsoft Project (MSP) training and creation of tools related to MSP timelines

🎯 Requirements

• Bachelor’s Degree or international equivalent required; Life Sciences preferred • Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP • Demonstrated successful experience in project/program management and matrix leadership • Excellent communication skills as needed for facilitation, negotiating, risk management • Excellent teamwork, organizational, interpersonal, and problem-solving skills • 3+ years of using Microsoft Project (MSP) or Planisware • 5+ years’ experience in pharmaceutical industry and/or clinical research organization • Experience in more than one therapeutic area is advantageous

🏖️ 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