Clinical Affairs Scientific Manager (19-0083)
Streck is recruiting for a Scientific Manager within our newly created Clinical Affairs area. This position is responsible for designing and writing study protocols in collaboration with R&D and the Biostatistician. Supervises and directs the design, implementation and monitoring of studies. Designs a timeline for study progress and ensures adherence to said timeline. Reviews and organizes data into an analyzable format. Troubleshoots issues and directs needed study design changes. Directs Clinical Affairs Technician performance and adherence to protocols.
The primary responsibilities include:
- Works in conjunction with the R&D personnel that supervised the research to produce the product(s) and the Biostatistician to develop the required experimental study designs and write inclusive study protocols that incorporate and support the regulatory strategic initiatives.
- Writes clinical trial study plans, including all applicable testing protocols and method sections. Closely monitors the execution of all clinical trials (i.e. data collection and projected time to completion) to gain assurance that the resulting performance data is effectively aligned with the planned product intended use and shelf-life claims.
- Develops a project timeline, monitors status and adherence to said timeline, evaluates resulting product performance data, reviews electronic records for accuracy and completeness and executes clear and concise reporting (i.e. communication) of all ongoing study designs to the Director of Clinical Affairs.
- Works with the Director of Clinical Affairs to identify hiring needs, screens and interviews prospective candidates and provides feedback/inputs as requested. Oversees career path opportunities, performance evaluations, including completion of performance ratings and recommendations for merit increases and mentoring/training.
Requirements include:
- Bachelor's degree in a scientific discipline with a suggested ≥ 15 years of hands-on laboratory experience in an academic or industry setting; or Master's degree in a scientific discipline with a suggested ≥ 10 years of hands-on laboratory experience in an academic or industry setting; or Ph.D. degree in a scientific discipline with a suggested ≥ 5 years of hands-on laboratory experience in an academic or industry setting.
- Relevant laboratory experience and performance may be substituted for an upper level degree or years of experience
- Prior project management experience.