Apac Clinical Operations Lead

* Drive impactful change in rare disease medicine, overseeing study management, site relationships, and strategic planning in a supportive and inclusive remote work environment.
Description
* Effectively oversee the management of multiple trials in designated regions.
* Lead the fulfillment of study requirements, timelines, and compliance within specific areas, aligning with global strategies.
* Facilitate strategic communication between various stakeholders involved in studies across different regions.
* Serve as an expert in policies, regulations, and related inspection processes.
* Foster and maintain relationships with various stakeholders, including investigator sites.
* Manage and execute study activities at the regional level, ensuring completion.
* Collaborate with partners to address study challenges and milestones proactively.
* Offer regional insights for the development of study documents and training materials.
* Identify potential study sites, conduct assessments, and provide recommendations.
* Support site initiation, close-out visits, and monitoring activities.
* Supervise the implementation of Monitoring Oversight Plans and assess quality metrics.
* Ensure the readiness and compliance of Trial Master Files, addressing risks and issues.
* Interact with peers to standardize study practices and enhance operational efficiency.
* Contribute to special projects and participate in the development of SOPs and guidelines.
* Provide guidance and mentorship to staff involved in Clinical Operations.
* Potentially lead a team within a collaborative environment, focusing on performance and development planning.
Profile
* University degree, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred
* Experience in pharmaceutical industry or relative academic experience
* Extensive knowledge of Clinical Operations, project management tools and processes
* Good experience of clinical development / drug development process in various phases of development and therapy areas.
* Knowledge of process improvement methodology
* Evidence of developing partnering skills
* Native level Japanese
* Business level English
Job Offer
* Lead and manage Clinical Operations for APAC R&D
* Contribute to expanding portfolio in ultra rare diseases
Page Group Japan is acting as an Employment Agency in relation to this vacancy.