Clinical Research Scientist

JOB DESCRIPTION:

- Serve as clinical expert for assigned clinical trials within the product team and provide input to decisions that may have clinical implications relative to his/her expertise.
- Provide guidance to Project Team on realistic clinical timelines and budgets.
- Responsible for clinical trial design across all Phases of clinical research for one or more projects across multiple therapeutic areas
- Coordinate and drive assigned clinical research studies with appropriate global and regional functions.
- Assist in protocol related training of clinical investigators
- Oversee study conduct in collaboration with Clinical Operations and Biometrics
- Work with Clinical Operations, CROs and trial sites to ensure expedient patient recruitment.
- Accurately interpret clinical study results and generate clinical study reports in collaboration with Biometrics
- Effectively collaborate with Global Franchise teams members and within the Clinical Development organizations to ensure study design and results are accurately communicated
- Write/review clinical efficacy and safety sections of regulatory dossiers.
- Ensure submission documents are accurate and of high quality.
- Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficientdetail oriented, with ability to work in a fast-paced environment
- Ability to effectively work in a cross-function Matrix environment
- Proficient experience in MS Word, Excel, PowerPoint, and Outlook
- Clinical Trial Safety Reporting
- Clinical Trials - Phase I