About the Role

　　Location: Hong Kong

　　About the role: We are seeking a Study Start-up stage project manager for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team.

　　Key Responsibilities:

　　• Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio. Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments

　　• Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects. Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable. Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required

　　• Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs). Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders. Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable

　　• Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements. Implements innovative and efficient processes which are in line with Novartis strategy

　　• Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team. Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned. In satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary

　　• Ensures sites are prepared for "Green Light" and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site "Green Light"

　　• Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required. Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead

　　Diversity & Inclusion / EEO

　　Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.

　　Role Requirements

　　Essential Requirements:

　　• A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable. Fluent in both written and spoken English, local language as needed

　　• Minimum 5 years' experience in clinical operations 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 trial set-up, execution, and monitoring

　　• Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues

　　• Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

　　Desirable Requirements:

　　• Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

　　• Strong interpersonal, negotiation and conflict resolution skills; Communicates effectively in a local/global matrixed environment

　　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 tru ste d 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!

　　Commitment to Diversity and Inclusion:

　　Novartis is committed to building an outstanding, inclusive work environment and diverse

　　teams representative of the patients and communities we serve.

　　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.

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　Hong Kong Special Administrative Region, China

　　Site

　　Hong Kong

　　Company / Legal Entity

　　NOVARTIS PHARMACEUTICALS (HK)

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No