Clinical Study Manager
Petaling Jaya, Malaysia
5 hari yang lepas

Job Description

6! 6 is the number of local and regional studies (different phases) that you will be overseeing for oncology portfolio.

Under the direction of the Medical Director Oncology or equivalent, the Clinical Study Manager is accountable for the day to day planning, executing and reporting, (from site feasibility up to and including study site close-

out), of assigned Innovative Medicines Phase I-IV Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements.

The CSM is the single point of contact and local study team lead, within the Country / Cluster, for the assigned studies and responsible for assuring aligned communication with Country / Cluster Clinical Research Associates (CRAs), CRA Managers and other key Country associates on the execution and progress of their studies.

Key Responsibilities

Trial Monitoring strategy

  • In collaboration with the Trial Monitoring key stakeholders (CSM Group Head, Regional Operations Manager (ROM), local / global medical, Trial Operations Manager (TOM), and global clinical assists in the development of local study execution plans and timeline commitments for a Country / Cluster.
  • 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 in collaboration with Country / Cluster Trial Monitoring and Medical.
  • Collects and manages input to the study protocol, and operational aspects of the study.

  • Leads site selection in collaboration with Country / Cluster Trial Monitoring and Medical.
  • Ensures that study start-up activities are conducted and completed on time, including preparation of IRB / EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs / CTA Hub for Health Authorities submissions, as required, in collaboration with Country / Cluster Trial Monitoring stakeholders.
  • Works with local Drug Supply Management, aligned with BPA, to forecast local IMP and comparator needs as appropriate. Ensures IMP is available to commence and complete assigned trial / assigned trial sites.
  • Oversees local vendor selection and performance as needed. Serves as main contact for quality / compliance issues, escalating as necessary.
  • Ensures sites are prepared for Ready to Initiate Site (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s).
  • Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country / Cluster personnel.
  • Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track.
  • Ensures recruitment targets are met and reviews enrollment at the site level including responsibility for approval of enrolling above site targets.
  • Also responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan.

    Minimum requirements

  • A degree in scientific or health discipline required and advanced degree with clinical trial experience and / or project management, is preferable.
  • Excellent communication skill.
  • 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.
  • Why consider Novartis? :

    750 million. That’s how many lives our products touch. 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.

    We are Novartis. Join us and help us reimagine medicine.

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

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