Note: The job is a remote job and is open to candidates in USA. Nektar Therapeutics is a company focused on advancing high-value therapeutics addressing unmet medical needs. The Director of Clinical Data Management will direct the planning and execution of clinical trial data management activities and manage CROs and service providers throughout the data management process.
Responsibilities
- Directs planning and execution of clinical trial data management activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database release
- Manages Contract Research Organizations (CROs) and service providers throughout the data management process life cycle, coordinating with Biostatistics, Clinical, and Regulatory teams to ensure accurate, efficient, and complete clinical trial data collection
- Supports the advancement of high-value therapeutics addressing unmet medical needs
Skills
- Demonstrated problem solving abilities and strong organizational skills
- Strong written and verbal communication skills
- Experience and understanding of ICH and GCP
- Demonstrates initiative and strong interpersonal collaboration
- Excellent project management skills
- Advanced knowledge of Data Management processes and systems
- A Bachelor's degree in clinical, biological, mathematical sciences or related field, or nursing qualification
- 13 years of pharmaceutical development experience with at least 6 years managing CROs
- Extensive experience in the design of clinical studies
- Strong computer skills with proficiency in Microsoft Project, Word and PowerPoint
- Solid understanding of clinical drug development processes
- Ability to develop data management processes and training
- Previous people management experience
- An advanced degree
- 10 years of previous management experience
Benefits
- Health Insurance (Medical/Dental/Vision)
- Disability Insurance
- Holiday Pay
- Paid Time Off (PTO)
- 401(k) Match
- Employee Stock Purchase Plan
- Wellness Programs
- Parental Leave Benefits (in accordance with the terms of applicable plans)
Company Overview
Company H1B Sponsorship