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Job ID

390953BR

About the role

Location: Shanghai / Beijing

About the role: We are seeking a Study Start-Up Manager to support country SSU strategy, be accountable for assigned start-up activities, prepare required submission documents and ensure TMF readiness.

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

Position Title

Study Start-Up Manager

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: 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

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Accessibility and Accommodation:

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 diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

Job Type

Full Time

Country

China

Work Location

Shanghai

Functional Area

Research & Development

Division

Development

Business Unit

GCO GDD

Employment Type

Regular

Company/Legal Entity

CNIBR Co. Ltd.

Commitment to Diversity & Inclusion:

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

Shift Work

No

Early Talent

No

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Confirmed 23 hours ago. Posted 30+ days ago.

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