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Jobs in Malaysia   »   Jobs in Petaling Jaya, Selangor   »   Business Management / Project / Planning jobs   »   Senior Clinical Project Manager

Senior Clinical Project Manager

Petaling Jaya, Selangor
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Job Description

About the Novartis Global Service Center in Kuala Lumpur:

The Novartis Global Service Center (NGSC) in Kuala Lumpur delivers a broad variety of services to the Novartis divisions worldwide. Kuala Lumpur is part of a globalized network of five NGSCs, which form a successful network of services minded associates partnering with the Novartis business around the world.

What makes NGSC special?
  • Attractive office location
  • Flexible time management
  • Truly multinational and dynamic organization
  • Multicultural environment and cross-functional hub location
Benefits of Working for Novartis
  • Competitive salary
  • Annual bonus
  • Strong work/life balance, flexible working hours
  • Life and Medical insurance scheme
  • Career Advancement & Competency Development
  • Rewards & Recognition
Job Purpose:

Accountable for all operational aspects of assigned clinical studies (interventional and non-interventional studies) executed by PLS Post Launch Scientific Support on behalf of Novartis Organizations. Lead Clinical Trial Teams responsible for full trial execution from protocol generation to clinical trial report/manuscript writing. Accountable for ongoing and effective collaboration with Sponsor, PLS Line Functions (medical writing, statistics, data management, monitoring, etc.), CPOs, other Novartis line functions and third-party vendors. Track performance and quality aspect.

Key Responsibilities
  • Agree with Sponsor team and PLS Line Functions on realistic project and trial timelines. Escalate to higher level in the organization if no agreement can be achieve.
  • Accountable for the writing of clinical protocols and related documents (i.e. risk management plan) in collaboration with the PLS or Sponsor Medical representative as appropriate: coordinate the clinical trial protocol development process; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from Sponsor. Collaborate with the Medical Advisors of the major Novartis local medical organizations to ensure country feedback are adequately integrated into protocol (as appropriate).
  • Lead the Clinical Trial Team and assigned resources to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.
  • Accountable for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence.
  • In collaboration with the PLS or Sponsor Medical representative, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
  • Ensure inputs are provided to clinical outsourcing specifications to facilitate bid templates and selection of vendors (e.g. central lab.).
  • Accountable for project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization/ allocation and country. Work closely with the Regional Monitoring Managers on trial feasibility and subsequent patient enrolment.
  • Work with PLS Line Functions and QA to identify potential quality issues and implement actions to resolve them. Work with PLS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality to the next level if no solution can be achieved.
  • Accountable for the development, management and tracking of trial budget working closely with the PLS Finance and Sponsor representative. Accountable for accuracy of trial information in all trial databases and tracking systems. Responsible for the preparation and presentation of the trial budget (SoW) to Sponsor representatives.
Why consider Novartis?:

927 million. That's how many lives our products touched in 2017. 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.

Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Minimum requirements

  • Have Advanced degree or equivalent education in Life Science / Healthcare is required.
  • Fluent and proficient in English and Mandarin (oral and written) as will need to support projects from China & Taiwan.
  • Have more than 10 years' experience in Clinical Operations with at least 7 years managerial experience in planning, executing, reporting and publishing clinical studies (interventional and non-interventional) in a pharmaceutical company or contract research organization.
  • Possesses proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).
  • Has good leadership, negotiation, presentation and project management skills
  • Has thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
Functional Area

Research & Development

Division

NBS

Business Unit

PLS NBS

Employment Type

Regular
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