PCRU Process and Procedure Project Manager

3 days ago


Groton, Connecticut, United States Innova Solutions Full time
Job Title: PCRU Process and Procedure Project Manager

Innova Solutions is seeking a highly skilled PCRU Process and Procedure Project Manager to join our team. As a key member of our organization, you will be responsible for managing the procedural documentation process, ensuring compliance with regulatory requirements, and driving process improvements.

Key Responsibilities:
  • Manage the lifecycle of procedural documents, including development, revision, harmonization, implementation, and maintenance.
  • Maintain procedural documentation in a manner that supports corporate compliance and inspection readiness objectives.
  • Collaborate with subject matter experts to identify changes or improvements required to procedural documentation.
  • Support SMEs in the creation of new CMCDs, as appropriate.
  • Ensure PCRU CMCDs meet regulatory requirements and are designed with operational effectiveness in mind.
  • Manage the CMCD lifecycle, including approval, posting, and training cycles.
  • Drive process improvements and adoption of global best practices.
  • Work proactively with training representatives to support the roll-out of new and revised processes.
  • Maintain a working knowledge of GCP/ICH Guidelines and applicable regulations.
Requirements:
  • Bachelor's Degree
  • 2+ years of experience in procedural document management
  • Enthusiasm for process improvement and document design
  • Capability to collaborate with peers
  • Knowledge of clinical trial operational processes and supporting systems and tools
  • Familiarity with project management tools
  • Strong written and verbal communication skills
  • Experience working with 21 CFR part 11 compliant document management/electronic signature software systems
Benefits:

Innova Solutions offers a comprehensive benefits package, including medical and pharmacy coverage, dental and vision insurance, 401(k), health savings account (HSA), flexible spending account (FSA), life insurance, pet insurance, short-term and long-term disability, accident and critical illness coverage, pre-paid legal and ID theft protection, sick time, and other types of paid leaves (as required by law), employee assistance program (EAP).

About Innova Solutions:

Innova Solutions is a global technology and business transformation solutions provider, employing approximately 50,000 professionals worldwide. We deliver strategic solutions to our clients, enabling them to operate as leaders within their fields. We are an Equal Opportunity Employer and prohibit any kind of unlawful discrimination and harassment. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [insert contact information].



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