ACI Federal, Inc.
Scientific Program Manager
ACI Federal, Inc., Bethesda, Maryland, us, 20811
ACI Federal
is seeking a highly ambitious, adaptable, structured, and detail-oriented
Scientific Program Manager
to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Allergy, Immunology, and Transplantation (DAIT) in
Bethesda, MD.
Technical Requirements:
Audit operations and systems to assess client satisfaction, conformance with SOP’s and regulatory compliance.Audit clinical study files held by the CRO.Review CRO standard operating procedures to ensure they meet industry standards, Good Clinical Practice (GCP) regulations.Identify Gap analysis of existing SOPs.Draft any required DAIT SOPs that describe the duties and responsibilities outlined above.Audit operations and systems to assess client satisfaction, conformance with SOPs and regulatory compliance.Review CRO standard operating procedures to ensure they meet industry standards, Good Clinical Practice (GCP) regulations.Draft any required DAIT SOPs that describe the duties and responsibilities outlined above.
Specific Qualifications:
Bachelor’s degree in a related field.Minimum of seven (7) years' experience as an Auditor Lead conducting reviews and audits of regulatory and clinical trial documents (trial master file documents) as related to ICH E6 guidelines, GxP, and applicable FDA regulation.Knowledge of GxPProficient in electronic systems used in clinical trials (such as Veeva, SharePoint, Electronic Data Capture, etc. and other quality management systems)Apply now!
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is seeking a highly ambitious, adaptable, structured, and detail-oriented
Scientific Program Manager
to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Allergy, Immunology, and Transplantation (DAIT) in
Bethesda, MD.
Technical Requirements:
Audit operations and systems to assess client satisfaction, conformance with SOP’s and regulatory compliance.Audit clinical study files held by the CRO.Review CRO standard operating procedures to ensure they meet industry standards, Good Clinical Practice (GCP) regulations.Identify Gap analysis of existing SOPs.Draft any required DAIT SOPs that describe the duties and responsibilities outlined above.Audit operations and systems to assess client satisfaction, conformance with SOPs and regulatory compliance.Review CRO standard operating procedures to ensure they meet industry standards, Good Clinical Practice (GCP) regulations.Draft any required DAIT SOPs that describe the duties and responsibilities outlined above.
Specific Qualifications:
Bachelor’s degree in a related field.Minimum of seven (7) years' experience as an Auditor Lead conducting reviews and audits of regulatory and clinical trial documents (trial master file documents) as related to ICH E6 guidelines, GxP, and applicable FDA regulation.Knowledge of GxPProficient in electronic systems used in clinical trials (such as Veeva, SharePoint, Electronic Data Capture, etc. and other quality management systems)Apply now!
#J-18808-Ljbffr