Job Description
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Location: Ireland - Athlone - OFFICE BASED Summarized Purpose The Records Management Specialist provides comprehensive support in records management and archive room operations by collaborating closely with both operations and quality assurance teams. This ensures that all records management tasks are executed in alignment with PPD standard operating procedures. Essential Functions Document Processing: Efficiently processes incoming lab-related and support documents, which includes scanning/imaging, indexing, and filing both paper and electronic records. Controlled Document Management: Oversees the activation and closure of controlled documents within computerized systems, ensuring accuracy and compliance. Issue Resolution: Acts as a liaison with operations to address and resolve any outstanding issues identified during records management activities. Records Retention Compliance: Collaborates with Quality Assurance (QA) management to ensure adherence to records retention periods as specified by regulations and internal policies. Document Maintenance: Maintains and updates controlled documents related to laboratory reporting, retention, and disposition, ensuring they are current and accessible. Archive Room Management: Manages the archive room, ensuring that records are stored securely and can be retrieved efficiently. QA Support: Assists with deliverables related to Quality Assurance, contributing to the overall compliance and quality objectives of the organization. Special Projects: Works independently on special projects as assigned, demonstrating initiative and the ability to manage tasks autonomously. Job Complexity Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice. Job Knowledge Applies acquired job skills and company policies and procedures to complete assigned tasks. Supervision Received Normally follows established procedures on routine work, requires instructions only on new assignments. Business Relationships Contacts are typically with individuals from all departments with PPD and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation. Qualifications: Education and Experience: Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years). Knowledge, Skills and Abilities: Sophisticated communication and interpersonal skills Excellent organizational skills and strong attention to detail with proven ability to handle multiple tasks efficiently and effectively Ability to effectively analyse project specific data/systems to ensure accuracy and efficiency Flexibility to reprioritize workload to meet changing project timelines Firm understanding of applicable systems including document management software and the eTMF Advanced computer skills Excellent English and grammar skills Working Conditions and Environment Work is performed in an office with exposure to electrical office equipment. Travel as required by special projects and supervisor needs. Long, varied hours required on occasion. Physical Requirements Frequently stationary for 4-6 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Routinely lifting and filing in overhead industrial filing system approximately 8 feet tall. Lifting of 25 lb. boxes of documents for filing, relocation within the facility, or in preparation for off-site storage and archiving. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. May interact with others, relating and gathering sensitive information. Interaction includes diverse groups. Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask. Regular and consistent attendance. #J-18808-Ljbffr