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)
Accountable for the performance and results of developmental programs
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
