Parexel are currently recruiting for an experienced Clinical Quality Manager (Senior), to join one of a large Sponsor’s in the EU. This role will manage the CDCM process and the document portal.
This role leads the development of departmental metrics and other reporting activities; facilitates/contributes to the process evaluation and integration of acquired company and/or asset related programs into Pfizer processes; contributes to compliance and audit/inspection readiness strategies and plans; and is responsible for ensuring high quality execution of controlled procedural documentation management

SOME SPECIFICS ABOUT THIS ADVERTISED ROLE

• Accountable to manage and implement the quality oversight plan for the process portal content containing 42,000 informational objects pertaining to process quality standards, global and local country & functional area.
• Act as a key subject matter expert in the process framework, process architecture, process modelling or standards and conventions. Advise, coach and train CMCD authors, Document Specialists, Process Owners, and other process experts.
• Oversee the activities of procedural document compliance staff; maintain consistent workflow, prioritize needs, and establish coverage, provide coaching and guidance to staff members.
• Facilitate/oversee the accuracy and completeness of process portal data by evaluating queries, performing data reviews, and reconciling findings to ensure accurate reporting.

WHAT WE ARE LOOKING FOR IN THIS ROLE

For every role, we look for professionals who have the determination and courage always to put patient well-being first.
That to us is working with heart.

Here are a few requirements specific to this advertised role.

• A scientific or technical degree is preferred.
• Specific training around:
• Process modelling, design, analysis and improvement methodologies and tools
• Data analytics, including data connections, query design, chart/visual development and tools
• BS and over 7 years; MS and over 5 years, or 10 years relevant experience in pharmaceutical industry.
• Experience in process design and modelling methods, demonstrated ability to design effective processes.
• Demonstrated experience in project management and implementation techniques.
• Previous continuous improvement experience considered a plus.
• A strong working knowledge and understanding of drug development processes, database structures, relational database management software, and data analysis tools.