SMA I II ICON plc is a world-leading healthcare intelligence and clinical research organization We re proud to foster an inclusive environment driving innovation and excellence and we welcome you to join us on our mission to shape the future of clinical development Job Purpose Study Management Associate SMA is a key member of the Global Study Team contributing to delivering the clinical study to time cost and quality and ensuring inspection readiness by taking oversight of study eTMF completeness The SMA role is designed to have a broader impact on the business by driving continuous improvement initiatives within their remit of expertise sharing best practices across the business with a focus on increasing operational delivery efficiency Key Responsibilities 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 set-up to study archival with a focus on setting up maintaining and ensuring completeness of internal systems databases tracking tools and project plans CSAP SMA works cross-functionally with internal and external partners on clinical study management activities as agreed with the Study Delivery Lead for in-house and outsourced studies across all phases and therapeutic areas in accordance with STOM current clinical study regulations and ICON procedures policies best practices and standards The SMA plays a key role in successful study delivery by providing subject matter expertise across key processes and systems throughout the study lifecycle SMA is responsible for monitoring study conduct and progress identifying resolving and escalating risks issues which may impact delivery of the study to required quality timeline and budget objectives SMA is responsible for reviewing key clinical documents including Protocols and Informed Consent Forms and for leading the development of study plans e g Monitoring Plan Vendor Management Plan Protocol Deviation Management Plan Risk Management Plan Communication Plan etc for internal and external use in assigned studies SMA facilitates and maintains interactions and meetings with internal stakeholders including regulatory LOC quality assurance monitors and external partners including CROs and third-party vendors to ensure successful delivery of assigned studies SMA is responsible for vendor management and CRO oversight acting as a primary point of contact overseeing study-specific deliverables and ensuring continued monitoring and timely delivery of activities delegated to third parties SMA is responsible for country oversight acting as a primary point of contact tracking recruitment progress data completeness and compliance and overseeing local budgets protocol deviations risks regulatory approvals and import license status SMA coordinates study-related activities and manages study team communications including meetings preparation scheduling minutes information spaces newsletters action logs communication plans and team lists SMA oversees delivery of clinical supplies investigational products and all study materials provided by ICON or external service providers communicates risks to supply continuity and proposes mitigation solutions as appropriate SMA ensures data oversight to maintain inspection readiness at all times including oversight of eTMF completeness eTMF setup periodic reviews follow-up on missing documents safety report dissemination ensuring documents are complete and quality-checked SMA supports budget oversight activities including management of task change orders expense tracking system reconciliation and escalation of financial issues to the SDL SMA actively contributes to squads in line with STOM requirements Education Requirements minimum expected Graduate Bachelor s degree in life sciences or a related field Job-Related Experience minimum requirements Graduate or Bachelor level with at least 4 year of relevant work experience in a pharmaceutical biotech or scientific environment Scientific background with knowledge of clinical trials including ICH-GCP and drug development processes is an asset Foundational knowledge of clinical study delivery processes regulations operational best practices and industry standards Familiarity with key clinical trial systems and experience using Trial Master File TMF industry standards Strong project management skills analytical and financial skills are preferred Excellent verbal and written communication skills in English Strong relationship-building and stakeholder management skills Other Job-Related Skills Good knowledge of applicable clinical trial regulatory requirements including GCP and ICH guidelines Ability to manage multiple competing priorities across studies with strong planning time management and prioritization skills Ability to work independently analyse and solve problems systematically and creatively using a risk-based approach Strong analytical thinking with attention to detail and a quality-focused mindset Understanding of project planning and project management principles Basic knowledge of project finance and accounting to support budgets invoices cross-charges and expense reviews Strong proficiency in Microsoft Office tools Excel PowerPoint Word Outlook Advanced Excel budget timeline tracking systems and CTMS knowledge are an asset Excellent written and verbal communication skills with strong interpersonal effectiveness Results-driven motivated and adaptable with the ability to thrive in a dynamic and changing environment Ability to work effectively within cross-functional squads using an agile delivery model Acts as a role model aligned with ICON core values demonstrating strong team spirit and the ability to work across cultures and geographies What ICON can offer you Our success depends on the quality of our people That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent In addition to your competitive salary ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family Our benefits examples include Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead Global Employee Assistance Programme TELUS Health offering 24-hour access to a global network of over 80 000 independent specialised professionals who are there to support you and your family s well-being Life assurance Flexible country-specific optional benefits including childcare vouchers bike purchase schemes discounted gym memberships subsidised travel passes health assessments among others Visit our careers site to read more about the benefits ICON offers At ICON inclusion belonging are fundamental to our culture and values We re dedicated to providing an inclusive and accessible workplace for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or protected veteran status If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please let us know Interested in the role but unsure if you meet all of the requirements We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles

📌 Sma I/ii (Karnataka)
🏢 ICON
📍 Karnataka