Clinical Document Management Specialist IV

divh2Clinical Document Management Specialist IV/h2pA Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing./ph3Job Description/h3pNOTE:/pulliTMF Background/liliPharma Industry experience (couple of years) Clinical Trial Experience (few years) GCP Experience (few years) Not senior level experience (doesnt need a decade worth of experience) Bachelors degree required/liliDay to day Mtg of TMF-early planning and setup all the way to study closeout and performing of consolations and archival activities/liliFocusing on TMF lifecycle as a whole TMF assigned specific trials to work on Day to day activities include:/liliQC of documents (paper and electronic)/liliTeam meetings (communicating issues to CTA/CRA) Filing/li/ulpJOB DESCRIPTION:/pulliReporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management Specialist (CDMS) is responsible for the management and oversight of Trial Master File (TMF) records from set-up through to final archival of the clinical trial, ensuring compliance with company SOPs and processes, and all applicable regulations./liliFocusing on inspection readiness, monitors compliance of the TMF and supports preparation of documentation required for regulatory agency inspections and internal audits./liliOversees set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. With support from the management team, performs periodic quality assessments of clinical TMF documents where required./liliContributes to assigned Clinical Document Management (CDM) initiatives./li/ulpRESPONSIBILITIES/pp70% Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of GCDO ensuring effective lifecycle management of the clinical section of the TMF./pulliKey contributor and member of the clinical study team/liliMonitors completeness and quality of the Clinical TMF, including elements outsourced to CRO/liliEnsures effective communication and issue escalation internally and with external vendors/liliOversees consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process./liliEnsures compilation of CSR appendices in accordance with Shires process/li/ulp20% Supports inspection readiness for GCDO through periodic quality assessment of clinical records./pulliEnsures clinical records are filed in a timely manner/liliWith direction from the CDM Manager, prepares clinical records for agency inspection./liliSupports assigned TMF corrective action plans under direction of Senior CDM/Manager./li/ulp10%/pulliSupports CDM initiatives to enhance efficiencies in document management practices/liliSupports Managers in training efforts for new personnel/li/ulh3Qualifications/h3pEDUCATION AND EXPERIENCE REQUIREMENTS/pulliMinimum 2 years of pharmaceutical industry experience/liliRecords management/TMF experience/liliFamiliarity with various aspects of clinical trials and regulatory submissions. Current awareness of regulatory requirements for clinical trials (ICH/GCP)./liliAssociates/Bachelors degree or equivalent preferred/li/ulpKey Skills, Abilities, and Competencies/pulliSufficient knowledge of regulatory requirements and ICH-GCP guidelines to support records management/liliDemonstrated ability to work independently, take initiative, complete tasks to deadlines/liliRequires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines/liliSolid communication skills and strong customer focus with ability to interact in a global, cross functional organization/liliAbility to communicate effectively with external vendors, including issue escalation, and responding to enquiries and concerns/liliMust be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands./liliExperience with use of Electronic Document Management Systems/liliAdvanced computer proficiency/liliDemonstrated ability to be flexible and to adapt quickly to change/liliAbility to multi-task/li/ulpOther Job Requirements/pulliFull driving license and passport required/liliDomestic (within country) and some potential international travel possible (10%)/li/ulh3Additional Information/h3pThanks/ppWarm regards Avleen Kaur View phone number on click.appcast.io/ppIm interested/p/div

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