GCP Compliance Manager (Remote) - Trova Talent

Position: GCP Compliance Manager

My client is seeking a GCP Compliance Manager that 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.
• Provide support with eTMF implementation, maintenance, and training activities.
• Ensures qualification of GCP vendors and manages the GCP audit calendar
• Perform TMF compliance checks to support the development and implementation of risk provide support with Inspection Readiness activities.
• Assist in Trial-Specific Training.
• Assess/ensure 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 to include but not limited to Clinical Protocols, Informed Consent Forms, Investigator’s Brochures, DSURs, Clinical Study Reports; and
• Performs such other duties as may be assigned to you from time to time.

Requirements:

• 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 in pharma 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 required. 
• Prior experience with BIMO inspections is strongly preferred. EMA/MHRA/PDMA inspection experience a plus.   
• Demonstrates analytical and critical thinking - Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review.
• Demonstrated working knowledge of the pharmaceutical industry including ICH/GCP guidelines.
• Have very strong communication skills, both verbal and written.
• Demonstrate 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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