- Contribute to Faster Delivery of Crucial and Lifesaving Therapies to the Market
- Partner with Innovative Research Organizations in Biotech, Pharma and Med Device
- US headquartered, innovative clinical technology company, leading in the field of randomization and trial supply management for the global lifesciences industry.
- Line management for project management and site management group
- Serve as primary contact with client to ensure communication is maintained and project schedules are adhered to.
- Lead problem solving and resolution efforts by assisting with issue identification, resolution, documentation, and escalation.
- Organize and participate in client meetings and respond to all client requests in a timely manner.
- Author data change requests based on client's needs.
- Coordinate the implementation and review of the data changes.
- Manage budget and Change Orders as required.
- Proactively review study data to identify trends or issues.
- Investigate issues and manage the resolution.
- Partner with other project managers on a cross functional basis to develop and implement business process improvement activities.
- Coordinate efforts towards data uploads (users, sites, randomization lists etc.) in the different environments
- Strong line management capabilties
- Strong communication skills, both verbal and written and in English and Japanese.
- Excellent presentation and negotiation skills; ability to present in front of an audience.
- Strong client management skills, including interpersonal skills; ability to build rapport and credibility with senior-level clients and internal partners.
- Superior time management skills and strong attention to detail.
- Analytical decision making.
- Extensive clinical research or project management experience
- Client management experience required
- Business analyst experience in a software environment preferred
- Experience in a clinical, CRO, or pharmaceutical operational function preferred
- Experience managing software development lifecycles (SDL) a plus
- Experience with TSM/IRT services delivery and eClinical systems implementation preferrered
- Opportunity to contribute to the growth of a global organization within Japan
- Leverage clinical trial experience and project management capabilities to deliver excellent customer service to sponsors, investigator and other external stakeholders
- Opportunity to work on global clinical trials and develop expertise in RTSM