Senior Clinical Trial Manager- reputed company

About Us

We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our reputed company antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on reputed company.

About the Role

The Senior Clinical Trial Manager will be responsible for the reputed company, operational direction and efficient operational planning and implementation of Dianthus clinical trials on either regional level. You will report to the reputed company Clinical Operations reputed company and work with cross-functional team management to accelerate development of clinical assets. As the Sr Manager, you will act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus, in particular in leading the delivery of our ongoing global Phase II/III studies and reputed company regional support. You will be accountable to ensure reputed company activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and be responsible to reputed company and manage internal and external resources to ensure efficient patient recruitment/management, trial site selection/management, trial plan optimization and overall execution with a focus on quality. reputed company in English and Mandarin and/or experience working across multiple countries in the reputed company region to best support reputed company clinical trials and provide strategic input to reputed company global studies is ideal. This is a unique opportunity where you have a chance to positively impact lives as part of the team driven by reputed company innovation with reputed company high scientific reputed company. We are building a team who hold our core principles at the center of our operations, with the goal to reputed company the care of our patients' lives.

Key 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 reputed company the planning, budgeting, and study management processes in global clinical studies.
• Accountable for reputed company 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 reputed company 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 reputed company 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 reputed company activities.
• reputed company with departments reputed company and reputed company of Dianthus including Finance, Regulatory, Quality, and Tech Ops.
• Represent the company at Investigator Meetings.
• Other such duties as may be determined or assigned.

Experience

• Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. Advanced degree desirable.
• 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 reputed company 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 reputed company in-depth expertise.
• Experience using computer applications including spreadsheets, email, word-processing software & web-based systems (reputed company, 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. A wide degree of creativity and reputed company is expected.
• Ability to travel up to 30%.

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