South Korea Job Openings

Novartis

Clinical Project Manager

FULL TIME

August 11, 2024

Summary

• Contributes, with appropriate oversight, to all relevant aspects of local clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. • May lead specific aspects of local clinical trial(s). • Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing and/or provide inputs to clinical development process. • Applicable to Clinical Project Manager provides clinical and scientific support through all phases of a clinical study in compliance with Novartis processes, ICH GCP and regulatory requirements. • This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. • The CPM is a core member of the Clinical Trial Team (CTT). In addition, the CPM supports/leads program level documents or activities as assigned.

About the Role

Internal Role Title: Clinical Project Manager

Location: Seoul, Korea #LI-Hybrid

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key Responsibilities:

Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality /compliance and performance standards.
Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
Ensuring proper handling of all study conduct and close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation (if in scope of the specific JD).
Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards.
Proactive operational planning with effective contingency and risk mitigation plans.
Adherence to Novartis policy and guidelines and external regulations
Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready.
High quality contributions to study/ program level and/or submission documents (e.g. IDP, protocol, ICF, clinical sections of CTA).
Strong leadership skills to be able to support management in team competency building, lead/contribute to local/global initiatives and best practice sharing across programs and/or departments
Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.

Essential Requirements:

+7 years of relevant experience and being familiar with domestic clinical trial-related regulations and GCP
Good understanding of the medical field and strategical managing skill on the local study with familiarity domestic regulations and global practices.
Problem solving in in ongoing competition and challenging situations

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is an Equal Opportunity Employer and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network

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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division

International

Business Unit

Innovative Medicines

Location

South Korea

Site

Seoul

Company / Legal Entity

KR01 (FCRS = KR001) Novartis Korea Limited

Functional Area

Research & Development

Job Type

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