This position will be office based in the King of Prussia, PA office.

This position is responsible for supporting the Director of the Records Management function within processes Business Process & Solutions, implementing and maintaining Records Management systems and processes in CDCS to ensure compliance:

• Consolidation of various records management vendors for cost effectiveness.
• Implementing a streamlined, global process.
• Ensuring compliance in how CDS stores, retrieves, refiles records.
• Performing yearly testing of the process to ensure success during both audits and inspections.
• Leading the decisions for accurate destruction of global records based on corporate retention guidelines.
• Oversee and supervise the strategy execution for the records management components of the electronic trial master file system (eTMF) and the CDS records management needs.
• Support the Director of Business Process & Solutions by performing delegated management tasks.
• Create Standard Operating Procedures (SOPs) and Work Instructions for job functions within Records Managements, discovering and documenting process improvements.
• Conduct initial contract negotiations with document archival vendors.
• Plan for ongoing storage needs of paper documents.
• Participate in Covance project teams and client meetings, as appropriate.
• Ensure compliance of deliverables to applicable regulations, guidance requirements and client requests.
• Coordinate and support the preparation and maintenance of project plans for Records Management projects and for subsequent adherence to the plans.
• Present aspects of Records Management to auditors during client and/or regulatory inspections.
• Any other duties as requested by management.

Recommended:

• 2 year college degree from an accredited institution or equivalent years of experience in records management function or life sciences.

Preferred:

• 4 year University/college degree form an accredited institution or equivalent years of experience.

Minimum Required:

• Project management experience.
• Experience of Record management, retention, requirements and systems utlized in records management for the pharmaceutical industry.

Preferred:

• 2 years' experience records management function in the pharmaceutical industry.