Main Areas of Responsibilities
supports the Clinical Program Lead and Clin.Sci. Lead in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy. key Clinical Development contact for the Clinical Trial Team and is responsible for:
- Representing Clinical Development as a core team member on the Clinical Trial Team
- Providing a clinical review of study-specific documentation and training materials
- Performing clinical data reviews
- Design eCRF, data capture, listings, review patient profiles to identify and resolve issues.
- Assessing reported protocol deviations
- Ensuring resolution of identified issues during clinical data and protocol deviation reviews cross-functionally and with Investigational sites in collaboration with the Clinical Trial Team
- Prepare for investigator meetings
- Minimum 5 years of relevant experience or equivalent combination of experience and education.
- Ability to travel up to at least 30% of time, including international travel
- Takes initiative to contribute clinically relevant scientific ideas and knowledge to team globally
- Understands and leverages cross-functional roles and responsibilities
- Ability to understand implications of strategic decisions
- Identifies and implements best practices
- Demonstrates basic understanding of global pharmaceutical/ device product development
Bachelor’s degree required, Advanced science degree (e.g., MS, MD, PharmD, PhD); Scientific knowledge and experience in multiple Therapeutic Areas preferred. (CNS, Pain, and Migraine a plus).
PLEASE ANSWER the following question
1. What is your experience with Data Review (designing E crf, or Jreview, clinical data, as examples)- and then they will ask what does that mean to you? So be ready to provide details
2. What is your expereince with Study Start up