Title: Process Modeling Specialist
Location: TITUSVILLE / NJ / 08560
Duration: 12 months (with possible extensions)
Job Description
General Summary: Responsible for design, planning, development and monitoring of clinical evaluation projects. Interprets research results and evaluates the safety, marketability and medical usefulness of drug and product candidates.
Duties & Responsibilities
Monitors clinical evaluation projects, experimental protocols and patient forms. Performs duties including protocol development, the maintenance of investigational sites, development of case report forms, informed consent, study drug projections and communication. Documents and reviews steps needed for data collection, analysis. Maintains correct standard operations, procedures and protocol. Participates in interpretation results for phase 14 investigations in preparing for new drug application to the appropriate governmental body. Adheres to clinical research guidelines and safety procedures. Acquires knowledge and full understanding of clinical trials documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies. Participates in verifying essential conditions that are necessary to determine the safety, efficacy, medical usefulness, and marketability of drug and product candidates. Communicates detailed outcomes and results of research findings to customer and management. Provides input to project planning and implementation activities. Prepares relevant registrations, submissions and reports. Serves as liaison to clinical sites and other vendors, as well as internal/external customers. Prepares research status and findings reports for internal/external meetings, including investigator meetings and company sponsored events.
- Will provide technical support for a manufacturing site
- Use processes and modeling for the role
- Must have data scientist exp
- Work with data coming from systems
- Use coding to transfer the data to better explain the process performance to leaders
- Must have visualization exp
- Must have Report Writing exp
- Must have Statistic and Analytical exp (ex: ANOVA, Regression, etc)
- Drug Product Manufacturing a big PLUS
- Exp with R and/or Python
Work Experience: Generally, Requires 2-4 Years Work Experience
Education Required: University/Bachelor’s Degree or Equivalent