inVentiv Health CMPL | Tokyo, Japan in Tokyo, Japan
Organization Overview inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market
Title CMPL | Tokyo, Japan
Job ID 13915
Position Overview The position providesleadership, mentoring, and technical support to the Clinical Monitoring team to ensure quality of deliverables and achievement of financial goals.
Create and deliver project level CRA training such as clinical monitoring plan, clinical monitoring aids and annotated visit reports.
Support development of study materials and present them at investigator or study launch meetings.
Distribute workload and site assignments within the clinical monitoring team.
Review monitoring reports within the timelines mandated by SOPs or monitoring plans.
Participate in business development proposals, defense meetings, and proposal development.
Ensure quality of the clinical monitoring deliverables within a project and maintain proper visibility of its progress by the use of tracking tools.
Ensure efficient dissemination of information across the CRA team
Interact with the client and other functional departments related to clinical monitoring activities and deliverables.
Ensure alignment of clinical activities to budget.
Support the identification of out of scope activities including the completion of clinical monitoring aspects of change orders.
Act as project manager on regional studies with limited scope of work.
Oversee CTA activities where they are related to clinical monitoring deliverables.
Complete assigned training programs and apply learning.
Perform administrative tasks.
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Five years prior clinical monitoring experience. Part of the required years of clinical experience can be compensated by Study Start-Up Lead experience.
Demonstrated ability to lead and align teams in the achievement of project milestones
Demonstrated capability of working in an international environment across regions, countries, and time zones
Knowledge of basic financial principles
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Strong and organizational skills
Must demonstrate good computer skills
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Ability to travel as necessary (approximately 20%)
Country Japan [JP]