The Senior Clinical Scientist will plan, implement, and manage clinical research studies in collaboration with internal and external stakeholders to ensure trial integrity and success.
Responsibilities include providing strategic input and development support for clinical plans, evaluating and interpreting clinical data, reviewing and authoring study-related documents, monitoring patient data and data collection status, and delivering protocol- related training to CROs, and clinical trial sites.
Responsibilities:
• Supports the creation of the clinical development plan in partnership with crossfunctional team members as well as KOLs and CROs
• Authors, manages, and reviews study materials for competent authorities’
submissions; gains insights from clinical and scientific experts
• Analyzes and interprets clinical trial data, collaborating with program lead to
conduct data review
• Troubleshoots internal and external conflicts to ensure trial integrity and success
• Develops and presents protocol training for CROs and trial sites
• Engages with trial sites and CROs on an on-going basis to monitor subject data and
data collection status, ensure adherence to protocol, and evaluate consistency of
data
• Maintains knowledge of the therapeutic area, current medical practice, and
pharmaceutical regulations to help ensure best practices
Competencies:
• Ability to proactively predict issues, resolve problems, and make sound decisions
• Excellent oral and written skills; ability to effectively communicate complex
information
• Ability to analyze & interpret clinical data
• Strong organizational abilities and attention to detail
• Ability to work independently and on a team
• Ability to effectively collaborate with internal and external stakeholders
• Strong understanding of drug drug interactions
Requirements:
• Bachelor's degree in science with 5 years related experience or
Master's degree and 3 years related experience; PharmD preferred
• Understands scientific & clinical research process
• Approximately 30% travel