Clinical / Scientific - Quality Assurance Manager
: Job Details :

Position Details: Our client, a world-leading Pharmaceutical Company in New Haven, CT or Groton, CT is currently looking for a Document Management Specialist to join their expanding team.Job Title: Document Management Specialist / Clinical Trials Process Duration: 22 months contract, extendable up to 36 monthsLocation: New Haven, CT or Groton, CTNote: The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.You may participate in the company group medical insurance planJob Description:Candidates must be local to New Haven and/or Groton sites.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) related to the both the Brussels and New Haven Pharmaceutical Clinical Research Unit sites.This position: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 SponsorROLE RESPONSIBILITIESMaintains an overview of existing procedural documents, both PCRU and GlobalTriggers revision cycles as appropriateCollaborates 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 standardsSupports SMEs in the creation of new CMCDs, as appropriateEnsures the PCRU CMCDs meet regulatory requirements, is designed with operational effectiveness in mind, and is harmonized across the PCRUs, when applicableManages the CMCD lifecycle; Manages the approval cycle, posting cycle and training cycleHelps drive process improvements and adoption of global best practicesWorks proactively with training representatives to support the roll-out of new and revised processesMaintains a working knowledge of GCP/ICH Guidelines as well as all applicable regulationsFollows CMCD management and training procedures.BASIC QUALIFICATIONSBachelor's Degree2+ 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 QUALIFICATIONSProject 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 processesInterview: TeamsShift/Hours: Monday - Friday first shiftWhat is the minimum education experience required?Bachelor's Degree2+ years of experience in procedural document management