Position Summary:
The Senior Manager will play a pivotal role in the Clinical Trial Oversight and Compliance function within the Clinical Operations department. This individual will assist with the development, implementation and maintenance of a proactive GCP compliance management system, including the development of processes and standards, training, and ensuring adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines. This individual will lead the implementation of a new Clinical Quality Issue Management process and system, including development of an effective training program. The individual will serve as a GCP compliance expert to the Cubist clinical development organization.
Key Responsibilities:
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Lead the implementation of a new Clinical Quality Issue Management process and system, including development of an effective training program for the clinical development organization
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Participate in and/or lead the development of additional internal process improvements related to GCP compliance
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Assist with development, implementation and maintenance of a robust GCP quality management system, including development of policies and procedures related to clinical research conduct
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Develop and deliver GCP and other relevant training to Cubist clinical research staff
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Assist with development of a GCP inspection readiness program
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Serve as subject matter expert concerning GCP and provide compliance guidance to internal Cubist clinical research personnel
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Proactively monitor and assess compliance risks within and across studies; collaborate to address identified compliance risks and promote a state of inspection readiness
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Liaise with R&D Quality Assurance to support audit and inspection activities
Minimum Basic Qualifications:
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Bachelors degree required
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10 years experience in Clinical Compliance, Clinical Research Monitoring, Clinical Trial Management, and/or , Clinical Quality Assurance within the pharmaceutical/biotech industry
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Extensive knowledge of FDA / global clinical trial regulations and ICH GCP Guidelines
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Understanding of the clinical development process and documentation requirements
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Proactive approach to GCP compliance
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Knowledge of outsourced models of clinical research conduct and associated sponsor requirements
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Knowledge of site and vendor auditing processes and recent FDA and EMA inspection findings
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Ability to work independently with minimal direction
Preferred Qualifications and Experience:
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Master’s degree preferred
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Experience building GCP quality systems, including development of SOPs, effective CAPA programs, and development/delivery of GCP-related training
Competencies:
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Collaborative, team player with a positive attitude and creative problem solving abilities
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Effective communication (written and verbal) and influencing skills
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Effective in building relationships, both external and internal to Cubist
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Strong organizational and project management skills
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Able to compile, analyze, and present data in a concise manner, in both written and oral context
Work Environment:
Physical Demands:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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