Key Responsibilities Include:-
• Works with staff at all levels in operational or business units to analyze, document and improve processes with the aim of satisfying the Parexel Corporate Quality goals of achieving breakthrough and continuous improvement.
• Work with SMEs in SBU’s and CAU’s to develop Standard Operating Procedures (SOP’s) from process maps and associates them to related documents within the Controlled Documents Library. Support lead authors in Work Instruction (WI) development.
• Drives updating of existing Controlled Documents and conversion to current formats, as necessary.
• Work with Parexel business units and corporate functional units to determine process related issues, needs to address operational performance requirements.
• Educate and advise business management on process improvement opportunities through the use of methodology, data and fact. • Employ recognized process improvement methodologies to eliminate waste and rework as well as break through improving business performance.
• Plays a key role in ensuring that up-to-date Controlled Documents are available to Parexel employees at all times. This includes coordination of Controlled Document life-cycle procedures and maintenance of the Controlled Documents Library.
• Checks process maps for completeness and format. • Management of Controlled Documents e-signature workflow.
• Receive, review and capture external requests for the viewing of Parexel Controlled Documents, thus supporting provisioning of external parties/clients to Parexel’s Controlled Documents.
• Receive, review and support planned deviations for the organization and ensuring these documents are e-signed and published in the Con-trolled Documents Library.
• Update Table of Contents which supports the business.
• Database maintenance.
• Posting and deleting documents in the Controlled Documents Library, ensuring current and obsolete versions are posted correctly. • Administrative work (filing, copying, formatting, editing, proofreading).
• Managing Stakeholder-approved Controlled Documents through the BPM process, including QC, e-signature workflow, Master Binder ad-ministration.
• Work with business and functional units to determine analytical tools needed for process analysis and improvement projects.
• Identifies areas for new approaches, processes and procedures to effect continuous improvement.
• Prepare project work and investigate, select, and identify specific tools for projects covering business area or functions, in-order to improve efficiency of project work.
• Assist in the development of methodology and training materials and provide process analysis and mapping training to staff in operational or business units, as required.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.QualificationsExperience & Qualification Requirements:-
* Educated to bachelor’s degree level (technology, biological science, pharmacy, business management or operational research or other related discipline preferred) or equivalent qualification.
* Related experience within clinical research is preferred.