Principal BT Analyst II at Syneos Health in Morrisville, NC
Responsible for quality and compliance activities within the Information Technology (IT) department with primary focus on representing all aspects of IT at audits and vendor assessments. Reviews computer systems and processes are in alignment with departmental Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) guidance and applicable clinical regulations including FDA 21 CFR part 11.
Essential Functions:
Coordinates the IT audit response across the IT departments in collaboration with Corporate Quality Assurance. Acts as the primary contact for IT during client and regulatory audits. Presents overview of IT and is the Subject Matter Expert for IT System Development Life Cycle, Computer System Validation and Departmental regulatory and procedural compliance. Assists in the creation, implementation, and assignment of IT CAPAs and Quality Issues (QI) generated from audit findings and manages follow-up activities to ensure timely closure of CAPAs and QIs assigned to the IT department. Provides input to IT compliance processes, procedures and activities based upon feedback outcomes from audits and assessments. Conducts reviews of IT procedures to ensure departmental practices are consistent with SOPs, regulatory guidance and industry best practices. Oversees the drafting and revisions of IT departmental SOPs with the appropriate departmental SOP authors and reviewers, and manages the SOP documents in alignment and collaboration with Corporate QA to ensure compliance with document controls. Coordinates training on departmental SOPs and collaborates with the Global Training team on the development and update of IT related training curriculums and certifications. #LI-CK1 Qualifications Experience 7-10 years in depth experience with clinical regulations pertaining to computer systems validation. Excellent communication skills, presentation, verbal and written. Ability to review documentation, synthesize and provide timely responses. Cross department and functional organizational skills.
Salary Range:
$100K -- $150K
Minimum Qualification
Business Intelligence & AnalyticsEstimated Salary: $20 to $28 per hour based on qualifications.
Essential Functions:
Coordinates the IT audit response across the IT departments in collaboration with Corporate Quality Assurance. Acts as the primary contact for IT during client and regulatory audits. Presents overview of IT and is the Subject Matter Expert for IT System Development Life Cycle, Computer System Validation and Departmental regulatory and procedural compliance. Assists in the creation, implementation, and assignment of IT CAPAs and Quality Issues (QI) generated from audit findings and manages follow-up activities to ensure timely closure of CAPAs and QIs assigned to the IT department. Provides input to IT compliance processes, procedures and activities based upon feedback outcomes from audits and assessments. Conducts reviews of IT procedures to ensure departmental practices are consistent with SOPs, regulatory guidance and industry best practices. Oversees the drafting and revisions of IT departmental SOPs with the appropriate departmental SOP authors and reviewers, and manages the SOP documents in alignment and collaboration with Corporate QA to ensure compliance with document controls. Coordinates training on departmental SOPs and collaborates with the Global Training team on the development and update of IT related training curriculums and certifications. #LI-CK1 Qualifications Experience 7-10 years in depth experience with clinical regulations pertaining to computer systems validation. Excellent communication skills, presentation, verbal and written. Ability to review documentation, synthesize and provide timely responses. Cross department and functional organizational skills.
Salary Range:
$100K -- $150K
Minimum Qualification
Business Intelligence & AnalyticsEstimated Salary: $20 to $28 per hour based on qualifications.
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