Senior Clinical Trial Manager – APAC
Dianthus Therapeutics, Inc.
Google Cloud Platform
Senior Clinical Trial Manager / Associate Director
Dianthus Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- The Senior Clinical Trial Manager/Associate Director will be responsible for the oversight, operational direction and efficient operational planning and implementation of Dianthus clinical trials on either regional or global level.
- You will report the Executive Director, Clinical Development Operations and work with cross-functional team management to accelerate development of clinical assets. As the Sr Manager/Associate Director, 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 III CIDP study and additional regional support for the planned phase III study. You will be accountable to ensure all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and be responsible to oversee 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.
Requirements
- 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 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. A wide degree of creativity and latitude is expected.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
- Highly effective verbal and written communication skills with internal and external stakeholders.
- Effectively collaborates with team members.
- Ability to travel (including internationally) and work across cultures.
Benefits
- Health insurance
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementclinical project managementbudget managementdrug development processclinical development planningclinical trial executionICH GCP guidelinesregulatory compliancepatient recruitmenttrial site management
Soft skills
problem-solvingmulti-taskingattention to detailindependent workteam collaborationeffective communicationcreativityproactive issue identificationorganizational skillscross-functional team management
Certifications
Undergraduate degree in Life SciencesRN degreeadvanced degree (desirable)
