Summary
About the Role
Major Accountabilities:
Study & Site Operations strategy
• Supports SSO Study Start-up Manager in the development of country study execution plans and timeline commitments
• Participates in the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
• Proactively identifies risk and opportunities for the assigned studies within the country and develops respective mitigation plans
Initiation and conduct of trials
• When requested by the SSO Feasibility Manager supports the study feasibility by providing input to the study protocol, and operational aspects of the study
• Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country personnel
• Drives the conduct of the study, (tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
・Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for getting approval from the STUDY LEADER on enrolling above site targets. Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
• Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and relevant regulations
• Leads/chairs country study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies
• Maintains oversight of country level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
• Coordinates the study handover process with CRAs and their managers to ensure proper documentation and communication, when necessary
• Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
Delivery of quality data and compliance to quality standards
• Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Conducts or coordinates local investigator meetings as needed and ensures relevant documentation of training is archived in the Trial Master File
• Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, develops risk management plans and communicates/ escalates to global teams and SSO Country Head Portfolio, as appropriate
• Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation
• Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
• Escalation point for issues in monitoring visit reports (MVRs) for the assigned studies. Responsible for evaluating trends identified in MVRs and communicating/escalating to global teams, as appropriate. Communicates with CRAs and their managers to ensure issue resolution in a timely manner
• Provides feedback about the quality of monitoring activities to CRA Managers, MSOM, SSO Country Managers, FSP/BiS line managers (as propriate) and local QA (when required per Novartis SOPs)
• Supports inspection readiness and submission preparation for monitoring related activities and assists and coordinates with country Portfolio Execution and Quality Assurance for internal audits organization and HA inspections, as required, and ensures implementation of corrective actions within specified timelines
• Participates in multidisciplinary taskforces to support continuous improvement initiatives
Budget and productivity
• Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study conduct
• Tracks study budget with appropriate study budget responsible in Country. Ensures timely TCF preparation and submission
• Processes invoiceable items for site level clinical study activities to allow timely payments
Education:
• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
Languages:
• Fluent in both written and spoken English
Experience/Professional requirement:
• Minimum 3 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
• Capable of leading in a matrix environment, without direct reports and working cross-border managing study in various countries
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
Competencies:
• Good project management capabilities with demonstrated ability to problem solve and mediate complex issues
• Thorough understanding of the international aspects of drug development process, including sufficient knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations
and Novartis standards
Skills & Knowledge:
• Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
• Communicates in a local/global matrixed environment
Why consider Novartis?
817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp
Japan
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。
健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
