Senior Study Manager – Infectious Disease, Vaccines

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🔥 1 minute ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 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

• May lead or support a study or studies, depending on size/complexity. • Operational point of contact for trial execution and all trial deliverables • Manages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) • Supports clinical (drug/vaccine) supplies planning • Manages deployment and interactions with external vendors (e.g., IVRS, PRO) • Initiates planning for Investigator meeting and protocol training. • Completes trial set-up and maintains CTMS • Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT • Initiates recruitment/retention planning & enrollment tracking • Responsible for tracking study related details (e.g., specimens, queries) • Oversees protocol training activities including IMs and CRAs training meetings • Ensures appropriate postings to investigative site portals • Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others) • Point of escalation for study related operational issues • Responsible for operational details at Operational Reviews • Responsible for creating and maintaining project schedule and collaborating with Program Lead • Sets up and maintains Trial Master File (eTMF) • Ensures alignment of budget with protocol needs • Responsible for executing protocol within the budget • Responsible for creating and maintaining ADI logs • Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group • Develops study related manuals (e.g., administrative binder, lab manuals) • Manages Emergency Unblinding (EUB) Call Center activities • Co-authors newsletters with CS • Approves contracts, invoice payments and change orders for vendors, as necessary • Responsible for end of study reconciliation (clinical & ancillary supplies) • Oversees all HQ close-out tasks • Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking • Supports CS activities as needed to achieve CTT deliverables • Interface with External Data Coordination and Data Management • Responsible for quality control and inspection readiness at all times • Responsible for risk assessment, mitigation planning and execution

🎯 Requirements

• BS/BA/MS/PhD with 7+ yrs clinical research experience • Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required. • Proven ability to meet aggressive timelines • MS Project experience preferred • Excellent Excel and PP skills required • TA- Infectious disease and/or vaccines experience highly preferred • Global experience required • Excellent oral (including presentation) and written communication, computer/database management, and project management skills required

🏖️ 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