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Dianthus Therapeutics, Inc. · 3 months ago

Senior Clinical Trial Manager- APAC

United States

Full-time

Remote

Senior Level

Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies for severe autoimmune and inflammatory diseases. The Senior Clinical Trial Manager will oversee clinical trials in the APAC region, ensuring compliance with regulations and efficient resource management while leading cross-functional teams to deliver clinical studies on time and within budget.

BiopharmaBiotechnologyHealth Care

Responsibilities

Manage and support relevant internal and external clinical operations resources while also contributing to strategy, tactics, and driving execution of global clinical studies

Influence, manage and lead the planning, budgeting, and study management processes in global clinical studies

Accountable for oversight and management of CRO/vendor partners contracted to the study / region assigned

Leads and supports the cross functional study team to successfully manage external service providers functional counterparts (including CRO(s), vendors and subcontractors), to ensure project deliverables are executed on time and within budget, whilst also taking on clinical trial management (CTM) role as needed

Leads/participates in clinical data review

Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans

Creates/supports scenario planning and risk benefit analyses to make recommendations to align with corporate strategies

Contribute to models of performance excellence by identifying best practices, reviewing measurement systems and improving operational efficiency in department

Manage relationships with vendor partners and suppliers in clinical programs to optimize delivery

Ensures efficient and effective communication and exchange of information across projects and reporting functions

May participate in Clinical submission activities

Supports the development and implementation of department level SOPs for clinical trials and related activities

Interface with departments within and outside of Dianthus including Finance, Regulatory, Quality, and Tech Ops

Represent the company at Investigator Meetings

Other such duties as may be determined or assigned

Qualification

Clinical trial managementRegulatory knowledgeBudget managementClinical development planningEDC systemsFluent in EnglishMandarinMulti-taskingTeam collaborationProblem-solving

Required

Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent

Experience in the pharmaceutical or biotechnology industry as a clinical research professional, including successful clinical trial management role and hands-on managerial experience executing high quality clinical trials from inception to completion

Excellent knowledge of international regulatory and ICH GCP guidelines

Experience in clinical trial management and managing high-functioning clinical trial project teams

Demonstrated ability to manage large complex budgets

Experience and understanding of the drug development process, clinical development planning and clinical trial execution

Understanding of clinical aspects of therapeutic area along with willingness to develop in-depth expertise

Experience using computer applications including spreadsheets, email, word-processing software & web-based systems (EDC, IVR/IWRS, CTMS)

Ability to work well independently as well as a member of multiple, integrated teams

Ability to contribute creative yet practical solutions to problems

Ability to multi-task and manage several projects in parallel while paying attention to detail