...appropriate.
• Advises internal teams on the application of drug and device laws and regulations, as well as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) as well as Good Manufacturing Practice (GMP) and...
...plans.
Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request.
May provide...
...plans.
Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
Leads medical responses to Requests for Proposals (RFPs) and Bid Defense Meetings (BDMs). May support Requests for...
...Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout. This may include...