What are the responsibilities and job description for the US Feasibility Manager position at Boehringer Ingelheim?
Responsible for the development and deployment of comprehensive country and site feasibility assessments across BI trials and programs within the US. Ensures recommendations are tactically feasible and considerate of the indications/assets from a holistic industry perspective. In close alignment with internal stakeholders, identifies highly capable investigators/sites to meet study requirements and business needs. Applies expertise as a systems and database subject matter expert to provide quality feasibility outputs. s and databases
- Experience as a Clinical Research Coordinator, Clinical Monitor, Field Monitor, or Site Manager is highly desired.
- Demonstrated experience in the regulated pharmaceutical or healthcare industry required; a minimum of at least four (4) years experience is preferred.
- Candidates should have experience managing global and local/regional feasibilities.
- Must have basic knowledge and experience in clinical medicine with an ability to evaluate data and scientific literature; must understand and implement FDA/ICH GCP regulations; in addition to advanced understanding of sponsor criteria necessary to qualify sites and staff to perform clinical human trials Phases I-IV.
- Thorough understanding of all phases of drug development (I-IV).
- Understanding of federal regulations pertaining to IND and NDA regulations.
- Excellent analytical skills and critical thinking abilities required, including an ability to anticipate issues and pro-actively problem-solve.
- Familiar with the supported Medical applications and an understanding of technologies used by these applications.
- Proficient in Word, Excel, Adobe Acrobat Professional.
Salary : $56