General Information

Location: Tokyo, Japan

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

The Clinical Scientist role supports projects from a clinical perspective across therapeutic areas in conjunction with project management. The Clinical Scientist is responsible for site rater training and the training and calibration of the clinicians.

EDUCATION REQUIREMENTS:
  • Graduate degree in psychology, social work, counseling, psychiatric nursing or related field required.

QUALIFICATIONS/EXPERIENCE:
  • Minimum 4 years’ experience administering psychiatric symptom rating scales and/or neurocognition scales, experience with structured diagnostic interviews preferred.
  • Minimum 3 years’ experience in a clinical trial or research setting or other clinical setting preferred.
  • Fluent in English, bi-lingual or multi-lingual skills are preferred.
  • Basic understanding of GCP.
  • Experience conducting assessments in CNS clinical trials as well as interacting with investigative sites and study sponsors.
  • Ability to function effectively in a fast-paced environment and manage multiple projects simultaneously.
  • Strong problem solving/decision making skills.
  • Proven project management experience at an intermediate level.
  • Solid understanding of basic and intermediate statistics.
  • Strong written and oral communication skills.
  • Strong interpersonal and organizational skills.
  • Demonstrate negotiation skills.
  • Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce detailed reports and presentations using these tools.

ESSENTIAL DUTIES/RESPONSIBILITIES: 
  • External facing clinical representative responsible for the independent clinical management of large, international clinical trials.
  • Liaise with sponsors and sites.
  • Oversee site rater qualification and training for Clinical Science.
  • Resolve assessment results inquiries raised by sites by working with Project Managers, and Clinical Science leadership as necessary.
  • Attend internal and external project meetings (e.g., weekly external client call, Investigators’ Meetings).
  • Review and monitor study level metrics; present study dashboards to sponsors as necessary.
  • Determine and inform appropriate management staff of study requirements (resource and training needs) while managing project specific rater resource requirements based upon projections.
  • Ensure clinical quality standards are met by monitoring internal clinician and team level performance across studies and scales and resolve clinical quality or training related issues.
  • Ensure calibration of clinical team members and conduct rater training events as specified in Training plans.
  • Provide clinical consultation to MedAvante-ProPhase Clinicians and site raters
  • Participate in the process of adding and removing clinicians from a study and ensuring they are assigned within designated timeframes.
  • Communicate with other departments (e.g., Project Management) to meet project objectives. Coordinate resources and develop materials for Investigator Meetings.
  • Assist with or take responsibility for the development of project deliverables (e.g., scale verification, electronic form development, training materials for in-person or online training, etc.)
  • Work with Business Development to review potential studies, RFPs, etc.
  • Participate in the development, execution, and integration of research that tests the scientific and conceptual basis for the MedAvante-ProPhase approach to issues of applied measurement;
  • Develop and maintain business and scientific relationships with external consultants, key opinion leaders, and Clinicians, both regionally and in research areas of interest, for the purposes of instudy delivery as well as academic projects
  • Report research results externally through peer-reviewed journals, conferences, or other appropriate venues;
  • Maintain calibration on relevant clinical scales.
  • Identify the need for and develop as needed work instructions, process guidelines and standard operating procedures and ensure processes and procedures meet SOP/GCP requirements.

SUPERVISORY RESPONSIBILITIES: 
The position may require the individual to be responsible for the management, direction, coordination, performance, and evaluation of an assigned team and staff. Responsibilities may include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

TRAVEL REQUIREMENTS: 
Ability to travel as required. Domestic and international travel may be required.

About Us: 

MedAvante-ProPhase, a subsidiary of WCG, was founded in 2002 with the goal of helping to bring better drug therapies to market through smarter, faster clinical trials. With this goal in mind, MedAvante set out to solve one of Pharma’s most intractable problems: the bias and variability that cause failed or inconclusive trials for Central Nervous System (CNS) therapies. A few years later, MedAvante experts pioneered Central Ratings and introduced the concept of Central Review utilizing their groundbreaking Virgil eSource solution.