PCRU Process & Procedure Project Manager

PCRU Process & Procedure Project Manager*Onsite in either Groton, CT or New Haven, CTSummary:The PCRU Process and Procedure Project Manager is dedicated to the management of the procedural documentation process. This role is responsible for managing the development, revision, harmonization, implementation, and maintenance of procedural documentation (standard operating procedures, work instructions, and all types of documents associated with procedures) related to both the Brussels and New Haven Pfizer Clinical Research Unit sites.Responsibilities:Maintain an overview of existing procedural documents, both PCRU and GlobalTrigger revision cycles as appropriateCollaborate 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 standardsSupport SMEs in the creation of new CMCDs, as appropriateEnsure the PCRU CMCDs meet regulatory requirements, are designed with operational effectiveness in mind, and are harmonized across the PCRUs, when applicableManage the CMCD lifecycle; manage the approval cycle, posting cycle, and training cycleHelp drive process improvements and adoption of global best practicesWork proactively with training representatives to support the roll-out of new and revised processesMaintain a working knowledge of GCP/ICH Guidelines as well as all applicable regulationsFollow CMCD management and training procedures.Minimum Qualifications:Bachelor's Degree in a related field requiredA minimum of 2+ years of experience in procedural document managementEnthusiasm for process improvement and document design; willingness to learn/adopt new ways of workingCapability to collaborate with peersKnowledge of clinical trial operational processes and supporting systems and toolsFamiliarity with project management toolsStrong written and verbal communication skillsExperience working with 21 CFR part 11 (or equivalent) compliant document management/electronic signature software systemsPreferred Qualifications:Project Management and inspection readiness experience strongly preferredComprehensive knowledge of GDMS and electronic signature processesProcess improvement/analysis/development experienceContinuous improvement methodology certification (e.g., Yellow Belt)Comprehensive knowledge of ICH-GCP practiceA strong working knowledge and understanding of drug development processesRate/Location:$40 - $44 per hourThis is a fully onsite role; candidates must be local to either New Haven, CT or Groton, CTMonday - Friday; first shift

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