- Work on the Forefront of Med Device Innovation Within the Cardiovascular Space
- Contribute to Operational Excellence of Clinical Trials in Medical Device
About Our Client
- Highly innovative and specialized US medical device company
- Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
- Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.
- Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.
- May assist with design, development, and monitoring of clinical evaluation projects.
- Trains investigators and site personnel.
- Includes headquarter and field clinical research associates (CRA).
- Implements and prepares the clinical development strategy as outlined by the clinical teams.
- May contact and recommend qualified investigators to perform studies and initiate clinical trials.
- Ensures recruitment and retention of patients.
The Successful Applicant
- Bachelor's Degree with extensive related experience in clinical operations either in Medical Device, CRO or Pharmaceutical
- Fluent Japanese, business level English
- 5+ years of clinical operations exepreince
- Experience working in a large Medical Device company Preferred
- Ability to manage employees and demonstrated informal mentoring and or peer leadership skills
- Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with the ability to drive achievement of objectives
- Knowledge of financial mechanism that relates to clinical trials
- Ability to develop and integrate metrics into the projects and operations that demonstrate the value of clinical trials to the business
- Strict attention to detail
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate management levels in the organization
- Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment Primarily interacts with internal subordinates and other supervisors
What's on Offer
Play a pivotal role in managing company sponsored clinical studies, bringing new medical devices from concept to commercialization