SMA I/II

Job description

SMA ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. # **Study Management Associate (SMA)** ## **Job Purpose** - The **Study Management Associate (SMA)** is a key member of the Global Study Team, contributing to the successful delivery of clinical studies within agreed timelines, budget, and quality standards while ensuring inspection readiness through oversight of study eTMF completeness. - The SMA role is designed to drive operational excellence by supporting continuous improvement initiatives, sharing best practices, and enhancing study delivery efficiency across the organization. ## **Key Responsibilities** - The SMA works in close partnership with the Study Manager (SM) and/or Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study start-up through study archival, with a focus on setting up, maintaining, and ensuring completeness of internal systems, databases, tracking tools, and project plans (CSAP). - Works cross-functionally with internal teams and external partners on clinical study management activities, as agreed with the Study Delivery Lead, for both in-house and outsourced studies across all phases and therapeutic areas, in accordance with STOM, applicable clinical trial regulations, and ICON procedures, policies, best practices, and standards. - Provides subject matter expertise across key study management processes and systems throughout the study lifecycle. - Monitors study conduct and progress, proactively identifying, resolving, and escalating risks or issues that could impact study quality, timelines, or budget. - Reviews key clinical documents, including Protocols and Informed Consent Forms, and supports the development of study plans such as: - Monitoring Plan - Vendor Management Plan - Protocol Deviation Management Plan - Risk Management Plan - Communication Plan - Facilitates and maintains effective communication and meetings with internal stakeholders (Regulatory, Local Operating Companies, Quality Assurance, Clinical Operations, Monitoring Teams, etc.) and external partners, including CROs and third-party vendors. - Manages vendor relationships and CRO oversight by acting as the primary point of contact, ensuring timely delivery of delegated activities and study-specific deliverables. - Provides country oversight by tracking: - Recruitment progress - Data completeness - Compliance metrics - Local budgets - Protocol deviations - Regulatory approvals - Import license status - Coordinates study team communications, including meeting scheduling, agenda preparation, minutes, action logs, newsletters, communication plans, team lists, and collaboration platforms. - Oversees the delivery of clinical supplies, investigational products, and study materials provided by ICON or external service providers while escalating supply risks and recommending mitigation plans. - Maintains inspection readiness through oversight of study data and eTMF completeness, including: - eTMF setup - Periodic quality reviews - Follow-up on missing documentation - Safety report dissemination - Verification of document quality and completeness - Supports budget oversight by managing Task Orders, Change Orders, expense tracking, reconciliation between financial systems and agreements, and escalating discrepancies to the Study Delivery Lead. - Actively contributes to Agile squads in accordance with STOM requirements. ## **Education Requirements** - Bachelor's Degree (or equivalent) in Life Sciences or a related scientific discipline. ## **Job Related Experience** - Bachelor's degree with a minimum of 4 **+ years of experience** in a pharmaceutical, biotechnology, CRO, or clinical research environment. - Scientific background with knowledge of clinical trials, ICH-GCP guidelines, and the drug development process is preferred. - Foundational understanding of clinical study delivery processes, applicable regulations, operational best practices, and industry standards. - Experience working with Clinical Trial Management Systems (CTMS), eTMF platforms, and industry-standard Trial Master File practices. - Strong project coordination and organizational skills, with analytical and financial awareness. - Excellent written and verbal communication skills in English. - Strong interpersonal and stakeholder management capabilities. ## **Other Job-Related Skills** - Good knowledge of applicable clinical trial regulations, including ICH-GCP and other relevant global regulatory requirements. - Ability to manage multiple competing priorities across several clinical studies through effective planning, prioritization, and time management. - Strong analytical and problem-solving skills with the ability to take a risk-based approach to decision-making. - Excellent attention to detail with a strong quality mindset and the ability to identify trends, inconsistencies, and potential risks. - Good understanding of project planning and project management principles. - Basic knowledge of project finance, budgeting, invoicing, expense management, and financial tracking. - Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook); advanced Excel skills and familiarity with budget tracking tools and CTMS are advantageous. - Outstanding communication, collaboration, and stakeholder engagement skills. - Results-oriented, proactive, adaptable, and able to thrive in a fast-paced and changing environment. - Ability to work effectively within cross-functional Agile teams. Demonstrates ICON's values through integrity, collaboration, accountability, innovation, and excellence while working effectively across diverse cultures and global teams.