ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.
Please note that this position is Japan-based and requires the successful candidate to live and work in Japan.
JOB SUMMARY: The Associate Clinical Scientist (ACS) is responsible for the coordination of the clinical aspects of multiple ongoing projects under the direction of the Director, Clinical Science. The ACS will assist in the development, implementation, and coordination of project-specific procedures for the successful management of clinical deliverables associated with a given project. The ACS works collaboratively with the entire Clinical Science team, cross-departmental study teams, and clients to ensure productivity and timely completion of scoped services.
EDUCATION REQUIREMENTS: Bachelor’s degree in life science discipline or other field relevant to MedAvante-ProPhase business focus is required. Graduate degree in life science discipline or other field relevant to MedAvante-ProPhase business focus preferred.
QUALIFICATIONS/EXPERIENCE:
- Two years of experience in the clinical research industry required; experience working for a biopharmaceutical sponsor or a clinical research organization preferred
- Minimum 2 years’ experience with the administration of clinical rating scales
- Experience conducting assessments in CNS clinical trials as well as interacting with investigative sites and study sponsors
- Ability to function independently and effectively in a fast-paced environment and manage multiple projects simultaneously
- Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
- Strong written and oral communication skills
- Ability to effectively work within a multifunctional team
- Fluency in English and Japanese required; multi-lingual skills are preferred
- Basic understanding of Good Clinical Practice (GCP)
- Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce detailed reports and presentations using these tools
ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.
- Collaborate with assigned Clinical Science team member(s) on various projects
- Assist with Rater Training and Qualification activities
- Liaise with sponsors and sites as required
- Liaise with all internal cross-departmental teams to ensure continuous and effective flow of communications in order to meet project deliverables
- Attend internal and external project meetings (e.g., weekly external client call etc.)
- Assist in the collection and monitoring of study level metrics, including tracking of queries, timeliness of remediations and completeness of responses to all inquiries
- Assist with tracking, facilitation, and completion of rater remediation
- Coordinate resources and develop materials for external meetings (e.g., Kick Off Meetings, Investigator Meetings, etc.)
- Identify the need for and contribute to the development of work instructions, process guidelines and standard operating procedures
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here
- Attendance and punctuality are essential functions of the position
TRAVEL REQUIREMENTS: This role may require up 20% travel which may be domestic or international, including overnight and weekend stays, consistent with project needs and office location.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work which includes sitting for long periods of time and occasionally required to lift 25lbs (11.3 kg). Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HCM.