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1+ months

Project Manager - Clinical Research

WIRB-Copernicus Group (WCG)
Tokyo, Japan

General Information

Location: Tokyo, Japan

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

Our MedAvante-ProPhase Project Managers are the primary point of contact for the client and are responsible for facilitating integrated project delivery, oversight, and project management of all phases of project life cycle. The Clinical Project Managers goal is to ensure optimal project performance including overseeing project scope and profitability, managing resource utilization, meeting key timelines and milestones, complying with quality and compliance standards, and achieving high level of client satisfaction.

Essential Duties/Responsibilities:

Project management encompasses the organization and delivery of all MedAvante-ProPhase core service offerings including but not limited to the following outlined below, based on contracts executed between MedAvante-ProPhase and its clients, tailored to specific projects:

General Project Management:

  • Leads the customization of key control documents (e.g., project plans, communication plans, project governance structure, etc.).
  • Develops and manages project timelines.
  • Leads internal and external conference calls.
  • Sets clear expectations for the team and establishes roles and responsibilities.
  • Demonstrates an understanding of client needs and manages satisfaction relative to high-quality deliverable.
  • Ensures profitability and utilization targets are met within the scope of work and budget. 
  • Communicates milestone billing completion to the Finance department.
  • Coordinates and communicates with clients and all other stakeholders (investigative sites, third party vendors, etc.) to ensure the alignment of planned objectives to activities.
  • Prepares project status documents and reports.
  • Assists in closing down and archiving systems.
  • Performs other daily tasks and special projects that support and contribute to the overall successful execution of the project life cycle.
  • Routinely tracks budget items and facilitates reconciliation for all services against scopes of work.

Rater Training:

  • Coordinates, schedules, and maintains a series of global training programs for raters working on clinical research studies.
  • Prepares training documents.
  • Assists in the development of rater training presentations.
  • Facilitates large scale training events (e.g., Investigators Meetings, Virtual Rater Training sessions).
  • Works with third party vendors to set up the eLearning workspace for raters according to project specifications.
  • Assists in the development of client training presentations, if applicable.
  • Coordinates and sets up data for system launch as necessary.
  • Coordinates distribution of materials to system end users.
  • Manages escalations of issues as outlined in the Project Plan. 

Scale Management:

  • Organizes, coordinates, and oversees translation, clinical review, and linguistic validation process.
  • Coordinates activities related to licensing, budgeting, and distribution of scales.
  • Provides oversight for distribution and shipment of scale binders through third party vendors.

Clinical Data Sciences:

  • Creates, implements, and maintains the project management and operational support components involved in expert review and consensus rating support for study sites.
  • Communicates with key technology vendors, including vendors of video and audio surveillance equipment and database solutions.
  • Creates, tests, and implements processes and workflows to support seamless management of clinical quality assurance data in study.
  • Leads and coordinates (conducts if appropriate) orientation for study site personnel and remote raters on equipment usage and workflow responsibilities for in-study activities.

Media Management:

  • Sets out pre-production, production, and post-production objectives and timelines in accordance to project timeline and key milestones.
  • Manages the timeline and cost of vendors conducting production and translation of all training materials.

Education Requirements: 

  • Bachelors degree required and/or 3-5 years related experience in a clinical project management environment (e.g.CRO, pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job.
  • PMP certification preferred.

Qualifications/Experience:

  • 3+ years of experience in project management in the pharmaceutical services industry or in a related industry (e.g., clinical research).
  • Excellent written and oral communication skills, organization, interpersonal skills, and ability to work with people from a variety of backgrounds.
  • Fluency in English required and multilingual fluency is a plus.

About Us:
MedAvante-ProPhase, a member of the WIRB-Copernicus Group (WCG,) is a global provider of specialty solutions in clinical trials. Our goal is to optimize the selection, use, and analysis of behavioral endpoints to mitigate trial risk and maximize the likelihood of study success. Through collaboration and evidence-based innovation, we work to transform measurement science in clinical trials and improve outcomes for all stakeholders. Our services support all measurement-related activities in clinical trials and include eCOA and Endpoint Surveillance, Rater Qualification and Training, and Study Start-Up Support. By partnering with Sponsors, CROs and sites, and using a risk-based approach, we deliver services that are highly customized to study needs and adapted regionally for global trials.

Categories

Posted: 2020-09-16 Expires: 2020-11-21

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Project Manager - Clinical Research

WIRB-Copernicus Group (WCG)
Tokyo, Japan

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