senior clinical project manager in Singapore

posted
contact
jin quan jonathan soh, randstad
job type
permanent
apply now

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
reference number
91M0131231_1552908679
contact
jin quan jonathan soh, randstad
apply now

job description

Job Summary:

Demonstrating result focus and strong initiative, you will be fully accountable for all
operational and strategic aspects of study conduct, for the flawless, efficient and smooth execution of the
Clinical trial while complying with internal Standard Operating Procedures, applicable laws and ICH Good
Clinical Practice. Manages high complex or high risk end-to-end clinical trials and possesses broad
knowledge in operations, R&D and business.

Key responsibilities & duties

  • Provides critical reviews and inputs of clinical operational aspects for development of Clinical Substantiation
  • Provides realistic timelines, states practical and valid operational models
  • Provides strategic and tactical guidance in risk management taking into account the business interests
  • Identification of project and clinical trial risks and the development and implementation of the mitigations for these risks
  • Contributes to the study protocol outline and study set up
  • Assesses & pronounces on clinical site(s) & staff & suitability to conduct the protocol.
  • Secures stakeholders agreement with the assessment outcomes.
  • Takes daily decisions in the best interest of the business and supervises the Clinical Project Manager (CPM) responsible of the day to day operations if applicable.
  • Ensures that the trial is progressing according to Clinical Development Unit (CDU) quality standards
  • Manages the risks and recommend corrective actions to improve efficiency and remove obstacles.
  • Reports on budget to concerned Strategic Business Unit (SBU) or business Project Manager.
  • Acts as Single Point of contact and bridge between the Business and CDU to maintain efficient communication flow on both sides.
  • Contributes to the strategy of the Clinical Management Group by identifying areas of improvement for increasing efficiency and innovations.

Requirements

  • Degree level in related scientific field
  • Minimum of 7+ years clinical project management experience in Food/Pharma/CRO industry
  • Proven experience in leading & coordinating the activities of cross-functional operational teams and communication with internal & external trial stakeholders
  • Experience of working with clinical sites to execute protocols
  • Experience of managing multi-site, international clinical studies (including vendor and clinical site selection, oversight and management; budget and contracts management).
  • Experience of risk assessment, implementation of mitigation plans and continuous review and adjust to plans as required.
  • Ability to convince, negotiate with and manage the expectations of key clinical trial stakeholders.
  • Co-ordination of investigational product preparation, logistics and management of supply throughout trial as well as management of biological sample logistics
  • Preparing and/or reviewing essential trial documents, maintenance of Trial Master Files and managing EC approval process.
  • Training and supervision of junior colleague's work.
  • Fluent in English. Fluency in Chinese will be an asset.


To apply online please use the 'apply' function, alternatively you may contact Jonathan at jonathan.soh @randstad.com.sg (EA: 94C3609/R1656945)






skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree