- Novo Nordisk Inc. (West Lebanon, IN)
- …that map to actionable and effective CAPA that reduce recurrent deviation types Lead and supervise the deviation investigation team, assign deviations based on ... investigator skill/experience and deviation type, ensure level-loading of ...opportunities are identified and corrected in a pre-deviation state Lead cross-functional investigation teams to identify root cause, evaluate… more
- Actalent (Noblesville, IN)
- …regulated industry such as pharmaceutical or chemical. * Support or serve as lead investigator for Out of Specifications results, identify and implement ... TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). * Support or serve as lead investigator for Exceptions to Standard Operating Procedures. * Generate or review Change… more
- Lilly (Indianapolis, IN)
- …supply chain daily/weekly issues + Trained to perform TrackWise activities such as Lead investigator and Change Owner + Provide operations project management ... and resolve issues occurring between the CMs and Lilly sites + Lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing… more
- Pipeline and Hazardous Materials Safety Administration (IN)
- Summary The incumbent serves as Chief Investigator within the Office of Hazardous Materials Safety (OHMS), Field Operations. The incumbent serves as the first line ... (PHMSA) hazardous materials accident investigation staff. Responsibilities A Chief Investigator 's duties will include: Supervise the hazardous materials accident… more
- J&J Family of Companies (Warsaw, IN)
- …direction. * Plan for study budgets and collaborate with Clinical Operations to lead the development of Investigator agreements and site contracts within fair ... market value (FMV), vendor agreements, payments, and financial disclosures. * Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and Biostats / Data Management teams, to enable optimized… more
- J&J Family of Companies (Indianapolis, IN)
- …Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and ... trial agreements and ancillary agreements for company sponsored and/or investigator -initiated studies through direct negotiation with clinical trial sites or… more
- J&J Family of Companies (Indianapolis, IN)
- …education of investigators, conduct of recruitment events, and participation in investigator meetings. Also provide support to investigator 's requests for ... Neuroscience scientific meetings including congresses, symposia, advisory boards, and investigator meetings. Interpret and report findings with recommendations for… more
- J&J Family of Companies (Indianapolis, IN)
- …documents such as, but not limited to, clinical study reports, investigator 's brochures, study protocols, summary documents, risk management plans, regulatory ... responses, and briefing documents. + Lead cross-functional document planning and review meetings. Interact with peer writers and colleagues from other departments.… more
- Merck (Indianapolis, IN)
- …for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The Regional Medical Scientific Director serves ... Enhances the comprehension of the scientific foundations and goals of investigator -sponsored research + Identifies barriers to patient enrollment and retention… more
- Community Health Network (Indianapolis, IN)
- …independently running and operating multiple research protocols in conjunction with the Principal Investigator and serves as a lead in the clinical research ... conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites in conjunction with the Clinical Research Manager. **Your… more
- Sanofi Group (Indianapolis, IN)
- …and identifying opportunities for further data collection clinical or investigator -led.** + Monitors disease epidemiology and provides support, including protocol ... as requested. + Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS), and supports ISS submissions through appropriate… more
- Merck (Indianapolis, IN)
- …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies and serve as a role model for other ... Enhances the comprehension of the scientific foundations and goals of investigator -sponsored research. + Identifies barriers to patient enrollment and retention… more
- Lilly (Indianapolis, IN)
- …ensure appropriate communication of risk to study subjects. + Participate in investigator identification and selection, in conjunction with clinical teams. + Ensure ... care professionals. + Prepare or review scientific information in response to investigator questions or media request. + Support data analysis and the development… more
- J&J Family of Companies (Indianapolis, IN)
- …documents such as, but not limited to, clinical study reports, investigator 's brochures, study protocols, summary documents, risk management plans, regulatory ... responses, and briefing documents. + Lead cross-functional document planning and review meetings. Interact with...peer writers and colleagues from other departments. Able to lead program-level or submission writing teams with supervision. Able… more
- Sanofi Group (Indianapolis, IN)
- …patients. **Job Description:** This position reports to the US MSL Field Lead , Immunology. **Main Job Responsibilities:** + Uses strong knowledge of relevant disease ... trials. + Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS) and supports ISS submissions through...truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those… more
- Sanofi Group (Indianapolis, IN)
- …patients. **Job Description:** This position reports to the US MSL Field Lead , Immunology. **Main Responsibilities:** + Uses strong knowledge of relevant disease and ... trials. + Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS), and supports ISS submissions through...truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those… more
- J&J Family of Companies (Indianapolis, IN)
- …management, data reviews and resolution. + Mentor and train junior employees + Lead in the investigation of all discrepancies in study documentation, by applying ... GCP and develop processes to mitigate reoccurrence throughout study phases + Lead in assessing current and new processes, finding opportunities and implementing… more
- J&J Family of Companies (Indianapolis, IN)
- …of the clinical studies in the development plan. ESSENTIAL FUNCTIONS: * Lead the project scientists, ensuring appropriate training, mentoring, and supervision across ... contract and budget templates to accelerate rate of site activations. * Co- lead and oversee clinical development/authorship of informed consent forms, eCRFs, study… more
- Sanofi Group (Indianapolis, IN)
- …patients. **Job Description:** This position reports to the US MSL Field Lead , Immunology. **Main Job Responsibilities:** + Uses strong knowledge of relevant disease ... trials. + Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS) and supports ISS submissions through...truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those… more
- Confluent (Indianapolis, IN)
- …Address questions and problem solve for escalated employee matters; serve as primary investigator as needed. + Engage with legal counsel as appropriate and identify ... require escalation + Partner closely with Finance, Legal, IT and external vendors to lead and influence all HR operations programs **What You Will Bring:** + 6+… more
