Senior Clinical Trial Manager / Associate Director
Dianthus Therapeutics, Inc.
Google Cloud Platform
Senior Clinical Trial Manager – APAC
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
- 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.
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementbudget managementclinical data reviewrisk benefit analysisoperational efficiencyclinical protocol developmentstudy managementdrug development processclinical development planningICH GCP guidelines
Soft skills
leadershipcommunicationproblem-solvingmulti-taskingteam collaborationstrategic thinkingrelationship managementcreativityattention to detailindependence
Certifications
Undergraduate degree in Life SciencesRN degreeadvanced degree (desirable)
