Clinical Study Manager - Onco
- Beijing, China
500+ On-going clinical trials; 160+ Projects in clinical development; 80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.
Your responsibilities include, but are not limited to:
• In collaboration with the Trial Monitoring key stakeholders, assists in the development of local study execution plans and timeline commitments. Participates in the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time Allocation, initiation and conduct of trials.
• Supports study feasibility and country patient commitments. Leads site selection in collaboration. Ensures that study start-up activities are conducted and completed on time. Works with local DSM to forecast local IMP and comparator needs as appropriate. Oversees local vendor selection and performance as needed.
• Ensures sites are prepared for RIS, and ensures all documentation is in place for drug release. Maintains a strong knowledge of the study protocol to answer standard operational questions. Drives the conduct of the study, to ensure all study operational aspects are on track. Ensures recruitment targets are met
• Oversees local clinical team activities to achieve study timelines and quality execution. Leads/chairs local study team meetings or supports Sr. CSM for local study team meetings, participates in global clinical trial team meetings. Maintains oversight of country level or assigned site level data management activities
• Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication. Tracks that all study close-out activities are performed in a timely manner Delivery of quality data and compliance to quality standards. Conducts or coordinates training for CRAs to support site readiness to recruit and study execution. Conducts or coordinates local investigator meetings
• Ensures 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, developing risk management plans. Is the escalation point for issues in monitoring visit reports (MVRs) for the assigned studies,
• Provides feedback about the quality of monitoring activities to CRA Managers and local QA as appropriate. Supports inspection readiness and submission preparation for monitoring related activities and assists with internal audits and HA inspections, and ensures implementation of corrective actions within specified timelines
What you'll bring to the role:
• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
• Fluent English (oral and written)
• Ability to communication externally in the country native language
• Minimum 5 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
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. 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.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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