Senior Manager, MAP, Patient Supply Operations

Posted 04 July 2024
Salary Competitive Daily Rate
Job type Contract
Discipline Clinical
Contact NameDaniel Jeffery

Job description

  • Lead the overall initiation, coordination, implementation, and management of the Material Acquisition Platform (MAP) program from start-up to closeout.
  • Lead the global study team dedicated to the study to ensure program goals and timelines are met.
  • Drive and manage relationships with internal stakeholders, KOL, surgeons, site staff and vendors.
  • Manage operational and technical aspects of the project including budgeting, study initiation and risk management.
  • Select, manage, and coordinate external vendors.
  • Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required.
  • Represent patient supply operations (PSO) on multi-function project teams internally and externally, report on study progress.
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans.
  • Ensure the delivery of the study according to ICH GCP, local applicable regulations, and the company’s specific SOPs, where applicable
  • Provide operational input (and scientific if appropriate) into protocol synopsis, study protocol and all other study-related documents.
  • Design, review, and approve all trial-related documentation, and establish study processes.
  • Develop or review and support SOP development or update.
Bachelor’s degree (BSc, BA, or RN equivalent) in a biological or science-related field is essential.
  • 4 years+ experience as a Project Manager in Pharma/Biotech preferred.
  • 5 years+ experience in clinical studies
  • Experience in immune-oncology early phase and cell therapy desired.
  • Strong experience in global setting and matrix environment
  • Strong experience in partnering with diverse teams and delivering results through taking ownership of key programmed components.
  • Previous experience of sites monitoring in oncology studies
  • Strong clinical, technical or disease area expertise
  • Knowledge of medical terminology and clinical patient management
  • Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers.
  • Knowledge of ICH-GCP guidelines
  • Ability to manage multiple projects.
  • Excellent communication, interpersonal, collaboration and organisational skills
  • Effective problem-solving skills
  • Attention to detail and timelines.
  • Computer literacy, proficiency in Microsoft Office
  • Experienced with the use of eCRFs and eTMF.
  • Ability to work independently and to effectively prioritise tasks