General Information

Location: Tokyo, Japan

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

Job Summary:  Our Clinical Assessment Managers works in a pivotal role of managing communication and activities among clinical research sites, Investigators, and company clinicians to prepare for and complete clinical assessments in accordance to the project specific scope of work.

Education Requirements: 

  • Bachelor’s Degree in health care, life sciences or related field with demonstrable related experience in pharmaceutical / biotechnology industry.

Qualifications / Experience: 

  • At least five (5) years of previous research experience and/or clinical experience is required.
  • CNS clinical trials experience is an advantage.
  • Experience working directly with or at a clinical research site is preferred
  • Ability to read, understand and assimilate protocol specified requirements and/or to ask appropriate questions as needed to gain knowledge and understanding.
  • Must possess knowledge of research design, patient care practices, GCPs, FDA regulations and a thorough knowledge of medical terminology.
  • Experience with an eCOA platform is a plus.
  • Proficient in common office technology e.g. Microsoft tools, teleconferencing, etc.
  • Ability to communicate and work effectively with a diverse team of professionals.
  • Excellent organizational, prioritization, time management and skills are required, detail-oriented, people-oriented, self-confident, flexible and adaptable to change. 
  • Must be able to read, write and speak English at a business level or above.

Essential Duties / Responsibilities:

  • Partner with project management, clinical science and eCOA teams to develop and implement project specific processes to successfully deliver the services as outlined in the scope of work related to clinical assessments
  • Ensure the Company standards and expectations in the Clinician Services are met and adhered to as measured by visit availability, wait times, clinician utilization, and safety reporting compliance.
  • Responsible for the resourcing of Principal Clinician (internal and external) ensuring that the study protocols scheduling of study assessments with sites and clinicians are met.
  • Develop presentations and conducts training of Investigators at Investigators´ Meetings and SIVs, or at any stage during the trial, to ensure the sites understand the role WCG MA-PP has with clinical assessments for the specific clinical trial.
  • Develop project specific manuals for the clinical assessments as outlined in the scope of work to ensure contracted services are clearly outlined and reflect all required requirements.
  • Mitigate risk related to clinical assessments as outlined in the project specific scope of work to ensure deliverables are met in a quality and efficient manner.
  • Oversee the onboarding of new clinical sites to ensure site readiness for clinical assessment activations in accordance to the project specific timeline.
  • Track and report progress of project, including subject, site and clinician compliance, scheduling metrics, risk related metrics to ensure deliverables and contracted deliverables are achieved on time and in quality manner.
  • Support reviews of clinical data in conjunction with the Clinical Scientist to perform clinical data risk assessments through gathering clinical data from the eCOA platform and analyzing in accordance with the CDRA plan.
  • Onboarding sites with project start up, including testing of equipment, mock assessments, and closeout activities related to clinical assessments
  • Develop project specific training materials for sites, as well as internal clinicians in conjunction with WCG MA-PP subject matter experts
  • Development of workflow procedures for study team based on specific project and study protocol.
  • Serve a primary point of contact for Clients, Investigators/Sites by interacting in a positive, professional manner.
  • Contribute to fostering team spirit and productivity by establishing communication lines within the project team.

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.