General Information

Location: Tokyo, Japan

Organization: Medavante-Prophase, Inc.

Job Type: Full Time - Regular

Description and Requirements

The Senior Project Coordinator provides support and acts as the lead for Site Management projects. They provide day to day direction to Site Management staff on site Management Projects, according to Company SOPs and Sponsor plans. This position provides quality customer service and assists in assuring that projects are delivered on time and according to client expectations. The Senior Project Coordinator is the liaison for project status, keeping managers of the Site Management and Project Management groups up to date and to ensure that there is a seamless assimilation of services.

EDUCATION REQUIREMENTS:

  • Bachelor’s degree life science required, or certification in a related allied health profession from an appropriately accredited institution and clinical trial experience preferred (e.g., nursing certification, medical or laboratory technology).

QUALIFICATIONS/EXPERIENCE:

  • Minimum 5 years’ clinical trial experience required or related experience and/or training in a clinical services environment required.

  • Knowledge of IRB regulations and submissions (informed consent, etc.) as well as a good understanding of good clinical practices (GCP) required.

  • Experience working with psychiatric (e.g. depressions, anxiety) indications preferred.

  • Experience working with technical solutions for Clinical Trials and directly with sponsors and sites.

  • Proven track record of successfully leading projects, process improvements, and taking initiative.

  • Thorough understanding of the clinical trial process.

  • Must be proficient in native language of Hub Office and/or English. Multi-lingual a plus.

  • Ability to work in a fast-paced environment and support multiple projects concurrently.

  • Strong planning, organization and problem-solving abilities.

  • Effective communication, oral and writing skills.

  • Proficient in MS Office, specifically Word, Excel and Outlook. Experience with Salesforce a plus.

  • Exceptional customer service skills.

  • Able to work flexible hours to provide support on a global basis as needed.

ESSENTIAL DUTIES/RESPONSIBILITIES:

  • Recognize, document and alert manager of trends to be addressed. Tracks issues for each project, identifying trends and informing/\escalating issues to management.

  • Interface with internal departments, such as Project Management, IT and Clinical Trial Services to ensure procedures are implemented and followed appropriately by the Site Management team and that the project deadlines are met.

  • Recommends solutions to streamline the efficiencies of internal department processes and assists with the design and implementation of these processes.

  • Update, track, and maintain study-specific trial management tools / systems. Set-up and maintain study files (study specific, investigator, etc.)

  • Serve as a subject matter expert on our internal systems to support MedAvante clinicians, investigative sites and project activities (this may include but is not limited to managing site rater training or assessment activities).

  • Provides exceptional and timely external customer support by determining requirements, answering inquiries, researching and exploring issues to resolution, escalating the issues as needed, and maintaining internal issue management application. Escalate issues as appropriate.

  • Assist with project implementation with highest customer satisfaction.

  • Train investigative sites on MedAvante-ProPhase study procedures.

  • Provide timely status reports to internal key stakeholders.

  • Monitors progress and initiates appropriate actions to achieve target objectives.

  • Interact with internal work groups to assist management with evaluating project resource needs, processes and timelines as needed.

  • Independently develops, prepares and delivers internal departmental documents including process related Work Instructions and Guidelines and project documents as needed.

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:

  • Domestic and international travel, approximately 10% of the time, including overnight stays as necessary, consistent with project needs and office location.

ABOUT US:
MedAvante-ProPhase, a subsidiary of WIRB-Copernicus Group (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.