IQVIA Global Trial Manager (GTM) - Novartis in Reading, United Kingdom
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Supports operational and some scientific aspects of global clinical trial(s), under the management of the (Associate) Global Trial Director. This person will be a core member of the Clinical Trial Team and support the (Associate) Global Trial Director to ensure all trial deliverables are met according to timelines, budget, operational procedures, quality /compliance and performance standards.
Development of specific sections of the protocol and related documents;
Development of study tools, guidelines and training materials;
Ensuring trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries);
Supporting the development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); supporting managing interface with CROs in cooperation with outsourcing management and line functions; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts;
Implementing issue resolution plans;
Supporting management of interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations;
Ensuring proper handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes. Extended member of the Global Clinical Team (GCT})
Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise.
Participate in data review as specified in the Data Review Plan.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Advanced degree in a health care or other scientific discipline or educational equivalent and a minimum of 3 years of on-site monitoring experience; or equivalent combination of education, training and experience
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Project/Trial Management and CRA or CRA management experience preferred
In depth therapeutic and clinical trial design/protocol/execution knowledge as provided in company training
Proven ability to handle operational challenges with minimal supervision
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Strong written and verbal communication skills including good command of English language
Excellent organizational and problem-solving skills
Effective time management skills
Ability to manage competing priorities
Good mentoring and training skills
Ability to establish and maintain effective working relationships with co-workers, managers and clients
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
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