MAO Trial Manager
Johnson & Johnson
Taipei, TW
2天前
  • Leads the SMT as the single point of accountability for end-to-end project management including high level budget estimate, protocol development, trial set-
  • up, execution, close-out, analysis and reporting.

  • For projects executed in-house, the TM will oversee and support Site Managers, GCO-LTM (if assigned) and other team members in the daily operational activities in line with country specific regulations and internal processes, if required.
  • For projects outsourced to a CRO, the TM will oversee and monitor the CRO’s performance on all contracted services.
  • Prepares or contributes to high level budget estimate in response to Request for Services followed by detailed budget proposal.
  • Leads vendor assessment and selection in consultation with appropriate representatives of the operating company.
  • Ensures accurate project budget management and tracking according to plan. Updates project account with scope changes, if any.
  • Is accountable for delivery of assigned trials within agreed / projected life of trial budget. Ensures accurate trial budget management and tracking, updates for scope changes and reconciliation of costs, as applicable.
  • Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.

  • Tracks project progress against planned timelines. Monitors patient recruitment rate to ensure that target enrollment will be met across the allocated regions / countries.
  • Provides regular status updates to SMT, project owners and Clinical Team members. Ensures required reports are generated and available for real time tracking of project status.
  • In coordination with the Functional Manager / CPL, Study Responsible Scientist / Physician (SRS / SRP) and / or Clinical Leader, the TM provides adequate project-
  • specific training to the GCO or CRO teams and to the site staff. Works with GCO / CRO staff in the set-up and coordination of Investigator Meetings, if applicable.

  • Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes.
  • Ensures quality oversight of assigned projects utilizing the available tools so that the project is in a constant state of inspection-

    readiness. Participates in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits.

  • Identifies and proactively manages issues in a timely manner.Communicates regularly with the Functional Manager / CPL / COH.
  • Escalates issues and manages risks related to resources, timelines and budgets.Build proposal for Action Plan(s) with the SMT to implement solutions on a project level.

    Qualifications

  • Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • Minimum of 5 years of clinical trial experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
  • Clinical operations knowledge, project management and proficient communication skills are required. Computer literacy is also required.
  • Excellent decision-making and strong financial management skills are essential for this position.
  • Effective study team leadership skills and proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage study teams in a virtual environment are needed.
  • Ability to work on multiple projects in parallel in different therapeutic areas is required.
  • Experience in managing all study types (interventional, non-interventional, registries) is preferred.
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