PCRU Process and Procedure Project Manager

1 month ago

Groton, United States The Fountain Group Full time

The Fountain Group is currently seeking an­­­­­ PCRU Process and Procedure Project Manager for a prominent client of ours. This position is located in New Haven and/or Groton site, CT. Details for the position are as follows:



Job Description:

  • Pay: $35 to $43hr – (W2).
  • Shift hours: 1st shift - Monday through Friday (Onsite).
  • 18 month assignment - possibility to extend or convert based off performance and budget. (No guarantees)
  • The PCRU Process and Procedure Project Manager is dedicated to the management of the procedural documentation process. This role is responsible to manage the development, revision, harmonization, implementation, and maintenance of procedural documentation (standard operating procedures, work instructions, and all types of documents associated with procedures).
  • Manages the lifecycle of procedural documents across both the New Haven and Brussels sites.
  • Maintains procedural documentation in a manner that supports corporate compliance and inspection readiness objectives.
  • Provides additional support / assistance when needed and as agreed with Pharmaceutical Sponsor.
  • Maintains an overview of existing procedural documents, both PCRU and Global.
  • Triggers revision cycles as appropriate.
  • Collaborates with subject matter experts to identify changes or improvements required to procedural documentation based on regulatory changes, audit/inspection findings, business needs, or changes in industry standards.
  • Supports SMEs in the creation of new CMCDs, as appropriate
  • Ensures the PCRU CMCDs meet regulatory requirements, is designed with operational effectiveness in mind, and is harmonized across the PCRUs, when applicable.
  • Manages the CMCD lifecycle; Manages the approval cycle, posting cycle and training cycle.
  • Helps drive process improvements and adoption of global best practices.
  • Works proactively with training representatives to support the roll-out of new and revised processes.
  • Maintains a working knowledge of GCP/ICH Guidelines as well as all applicable regulations.
  • Follows CMCD management and training procedures.


Qualifications:

  • Bachelor's Degree.
  • 2+ years of experience in procedural document management.
  • Enthusiasm for process improvement and document design; willingness to learn / adopt new ways of working.
  • 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 (or equivalent) compliant document management / electronic signature software systems.


Preferred Qualifications:

  • Project Management and inspection readiness experience strongly preferred.
  • Comprehensive knowledge of GDMS and electronic signature processes.
  • Process improvement / analysis / development experience.
  • Continuous improvement methodology certification (e.g., Yellow Belt).
  • Comprehensive knowledge of ICH-GCP practice.
  • A strong working knowledge and understanding of drug development processes.

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