Position Summary
As a Clinical Trial Manager (start-up) you will be a key contributor to Ascendis’ most complex and high priority clinical trials by supporting the Lead CTM/project lead and trial team, with an emphasis on trial start-up activities. You will do this by leading and tracking time critical activities such as site document collection and tracking, submission to authorities and IRBs and coordination of logistical requirements. You will have frequent and direct communication with site staff, vendors and internal stakeholders. You will report to the Director, US Clinical Operations and be part of a truly global clinical organization with locations in US, Germany and Denmark. The position is based in Palo Alto, CA.
Key Responsibilities
- Plan, drive and coordinate operational aspects of clinical trial start up to ensure fastest possible clinical trial initiation and subsequent enrollment across one or more study/studies
- Support clinical trials according to ICH/GCP regulations and internal procedures
- Liaise with internal and external stakeholders to ensure efficient exchange of knowledge and documents as well as avoidance of responsibility or communication gaps
- Participate in study team meetings, tracks study issues and provides regular metrics.
- Build and maintain a knowledge base of local region/country/site requirements in relation to clinical trial start-up
- Develop and maintain standards and process, ensuring efficiencies across multiple clinical trial with an emphasis on startup activities
- Contribute to Ascendis’ clinical Quality Management System
Requirements
- Minimum BSc or MSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
- At least 5 years of experience within clinical operations from a CRO or the pharmaceutical industry; ideally in activities related to trial start up
- Experience working with external providers of clinical services
- Understanding of adjacent key functions; particularly Regulatory Affairs, Clinical Trial Supplies, Logistics, Medical and Compliance
- Structured, organized and a proactive problem-solver, striking the right balance between detail and progress
- Confident decision maker
- Strong project management, communication and presentation skills
- Comfortable working in global/virtual teams across time zones
- Site monitoring experience a plus
- High proficiency in English
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance