Clincial Data Manager - Project Manager

Japan Permanent Foreign Multinational
  • Utilize Data Management Expertise to Expedite Clinical Trials
  • Contribute to Approval of Innovative Medicines

About Our Client

  • Leading full service global CRO, with high expertise in oncology and neuroscience

Job Description

  • Creation of management timelines related to data management operations
  • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
  • Provides project specific training to internal and external audiences as required
  • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed
  • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management
    Supports the management of resources on assigned projects/programs
  • Plan, manages and requests resources for assigned projects
  • Develop and maintain project plans, specifications and documentation in line with SOP requirements
  • Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date
  • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings
  • Plans for and creates necessary documentation to support internal and external audits; participates in such audits
  • Trains and mentors data management staff, acts as a subject matter expert
  • Prepares input for, and participates in proposal bid defence meetings
  • Maintains proficiency in Data Management systems and processes through regular training.

The Successful Applicant

  • Bachelors degree (Science, Engineering, Pharmaceutical Sciences)
  • Extensive data management operations experience for clinical trials
  • Experience in using EDC
  • Smooth communication, business level English
  • General knowledge about IT
  • Knowledge about SAS programming
  • Knowledge of CDISC standards
  • Knowledge of biostatistics

What's on Offer

  • Work in an international environment, clear career development opportunities, contribute to global clinical studies
  • Effective oral and written communication skills in Japanese and English.
  • Strong presentation skills
  • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
  • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team.
  • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment.
  • Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management
Contact
Ed Marsden
Quote job ref
4174013
Phone number
+813 6832 8981

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
4174013
Company Type