The University of Texas MD Anderson Cancer Center
GCP Compliance Manager (REMOTE)
The University of Texas MD Anderson Cancer Center, San Diego, California, United States, 92189
Job Title:
GCP Compliance Manager
Job Number:
35500
Location:
San Diego, CA
Salary:
$130-140K, Remote
Job Description:
The GCP Compliance Manager will provide compliance oversight. This role will also control GCP activities and provide management of clinical quality issues, deviations, and audits.
Responsibilities:
Supports the development, implementation, and maintenance of systems to advance the GCP compliance of the organization.
Provides GCP strategic support to clinical study teams and establishes measures to reduce compliance risks and enhance successful clinical trial conduct.
Collaborates closely with Quality Assurance, Regulatory Affairs, and the Clinical team in the development of internal policies and standard operating procedures (SOP) to ensure GCP compliance.
Provides support with eTMF implementation, maintenance, and training activities.
Ensures qualification of GCP vendors and manages the GCP audit calendar.
Performs TMF compliance checks to support the development and implementation of risk management and provides support with Inspection Readiness activities.
Assists in Trial-Specific Training.
Assesses/ensures proper documentation of any Clinical Operations process deviations.
Collaborates with clinical trial teams to identify operational issues/processes and opportunities for improvements to ensure achievement of trial milestones, data quality, and data integrity.
Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety & PV, Clinical Supply, and clinical vendors (e.g., central laboratory, CROs), as needed.
Manages clinical CAPAs and conducts root cause investigations related to clinical deviations.
Manages compliance assessment and mitigation processes.
Reviews essential documents for adherence to GCPs, including but not limited to Clinical Protocols, Informed Consent Forms, Investigator’s Brochures, DSURs, Clinical Study Reports.
Performs such other duties as may be assigned to you from time to time.
Required Skills:
Minimum of bachelor's degree in a scientific or related discipline.
At least 3-5 years of eTMF experience required, including experience in study start-up, study maintenance, and quality reviews.
6+ years’ experience with an industrial pharmaceutical company with relevant experience in clinical trials related roles (i.e., clinical operations and project management).
Experience performing quality assurance and/or quality management activities.
Experience with GCP vendor and site audits desired.
Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.
Demonstrates analytical and critical thinking skills.
Demonstrated working knowledge of the pharmaceutical industry including ICH/GCP guidelines.
Prior experience with BIMO inspections desired; EMA/MHRA/PDMA inspection experience a plus.
Strong communication skills, both verbal and written.
Demonstrated leadership abilities and problem-solving skills.
Able to translate strategy into operations and manage multiple changing priorities.
Ability to work independently with limited supervision.
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GCP Compliance Manager
Job Number:
35500
Location:
San Diego, CA
Salary:
$130-140K, Remote
Job Description:
The GCP Compliance Manager will provide compliance oversight. This role will also control GCP activities and provide management of clinical quality issues, deviations, and audits.
Responsibilities:
Supports the development, implementation, and maintenance of systems to advance the GCP compliance of the organization.
Provides GCP strategic support to clinical study teams and establishes measures to reduce compliance risks and enhance successful clinical trial conduct.
Collaborates closely with Quality Assurance, Regulatory Affairs, and the Clinical team in the development of internal policies and standard operating procedures (SOP) to ensure GCP compliance.
Provides support with eTMF implementation, maintenance, and training activities.
Ensures qualification of GCP vendors and manages the GCP audit calendar.
Performs TMF compliance checks to support the development and implementation of risk management and provides support with Inspection Readiness activities.
Assists in Trial-Specific Training.
Assesses/ensures proper documentation of any Clinical Operations process deviations.
Collaborates with clinical trial teams to identify operational issues/processes and opportunities for improvements to ensure achievement of trial milestones, data quality, and data integrity.
Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety & PV, Clinical Supply, and clinical vendors (e.g., central laboratory, CROs), as needed.
Manages clinical CAPAs and conducts root cause investigations related to clinical deviations.
Manages compliance assessment and mitigation processes.
Reviews essential documents for adherence to GCPs, including but not limited to Clinical Protocols, Informed Consent Forms, Investigator’s Brochures, DSURs, Clinical Study Reports.
Performs such other duties as may be assigned to you from time to time.
Required Skills:
Minimum of bachelor's degree in a scientific or related discipline.
At least 3-5 years of eTMF experience required, including experience in study start-up, study maintenance, and quality reviews.
6+ years’ experience with an industrial pharmaceutical company with relevant experience in clinical trials related roles (i.e., clinical operations and project management).
Experience performing quality assurance and/or quality management activities.
Experience with GCP vendor and site audits desired.
Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines is desirable.
Demonstrates analytical and critical thinking skills.
Demonstrated working knowledge of the pharmaceutical industry including ICH/GCP guidelines.
Prior experience with BIMO inspections desired; EMA/MHRA/PDMA inspection experience a plus.
Strong communication skills, both verbal and written.
Demonstrated leadership abilities and problem-solving skills.
Able to translate strategy into operations and manage multiple changing priorities.
Ability to work independently with limited supervision.
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