Clinical Trial Manager, Associate Director, Japan
Ebisu, Japan, -
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The Associate Director, Clinical Project Management - Japan is responsible to plan, lead and oversee the operational execution of Teva’s clinical programs in Japan across all indications from Phase I to Phase IV, in terms of cost, quality, timeliness and efficiency, while assuring patient safety and data quality and integrity. The position has a key coordinating role supporting all clinical operational activities for Teva R&D in Japan, embedded in the Global Clinical Operations organization, working according to the respective processes and networking with internal and external stakeholders. Proper planning, management, and reporting of clinical studies is part of the role as well as budget/timelines oversight, support interaction with the Japan agencies on clinical questions with respective to operational feasibility/execution and collaboration with investigators and Contract Research Organizations. At study level this position is answerable to Global clin ops program lead and/or Lead CPM.
How you’ll spend your day
- Lead the development of the local operational plans for clinical deliverables for assigned programs, effectively implementing design excellence in line with the Clinical Development Plan (CDP) and Global operational project management plan
- Participate in global departmental core activity processes and tasks, such as regular global operation team meeting
- Ensure alignment of operational plans and activities with the overall Clinical Development Team strategy while maintaining effective communication, including identification of risks and points of escalation
- May participate in due diligence activities by providing operational input as appropriate
- Collaborate with CQA to establish local audit plan to ensure timely resolution of CQA audit findings and collaborate with Inspection readiness to ensure study is ready for inspection (if applicable)
- Oversee management of Japan local CROs, local vendors and consultants, working closely with Procurement/ Lead CPM for performance and quality metrics
- Ensure effective collaboration between global and local CROs by liaising with vendors and Teva functions
- Assist with site activations as necessary and review translated essential documents
- Conduct and/or ensure completion of all oversight activities (e.g. oversight site visits, monitoring report review) as per the study vendor management plan
- Ensure the appropriate information is communicated to management including but not limited to KPIs, achievements, risks, and mitigation plans
- Ensure compliance with Quality standards (SOPs, GCP, etc.)
- Plan and manage local Investigators’ and Kick-off meetings in close collaboration with the Global teams, including the study vendors
- Ensure that all local essential documents are present and that the TMF is complete
- Develop in-depth knowledge in relevant indications and clinical trials methodology and applies the relevant information in recommending changes to better satisfy business requirements
- Assist local CRO-CRA to Support Site Engagement for clinical studies in Japan
- Evaluate clinical operation strategies to meet requirements for approval of products in Japan
- Prepare scientific or medical documentation to support clinical studies or regulatory procedures
- May support Japan Reference Listed Drug (RLD)/comparator sourcing, purchasing and shipping
- Support regulatory affairs teams in dossier preparation, especially CSR and its appendix
- Evaluate, develop, manage and optimize vendor portfolio in Japan
Your experience and qualifications
- BA degree (preferred Graduate/MSc degree) in applicable discipline (medical/pharmaceutical sciences)
- Strong management and supervisory experience in a global company. Can be experienced in managing and developing a group of people for a minimum of 2 years
- Extensive knowledge of GCPs, ICH guidelines, clinical operations and Japan regulations
- Strong experience in vendor and CRO management
- Experience in process improvement and design as well as project management and budget expertise
- Experience as an operations person in obtaining JNDA approval for one or more NCE products
- Experience in receiving and managing PMDA GCP inspections
- Good Information Technologies orientation
- Good English language knowledge
- At least 8 years previous experience in innovative medicine pharmaceutical industry or 8 years over all combined experience in a Contract Research Organization and innovative pharmaceutical industry, sound knowledge of the clinical landscape in Japan
- Travel Requirements: Ability to travel with overnight stays, as necessary, up to 30%
Make a difference with Teva Pharmaceuticals
Please submit your CV and a Cover Letter.
Please note that only shortlisted candidates will be contacted.
Reports To
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