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Clinical Document Management Specialist IV

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Biotech and Pharmaceutical, Calendar Management, Clinical Data Management, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Corporate Compliance, Corrective Action, Cross-Functional, Customer Relations, Detail Oriented, Document Management, Driver's License, Establish Priorities, GCP (Good Clinical Practices), Healthcare Quality, ICH Regulations, Information Technology & Information Systems, Internal Audit, Maintain Compliance, Medical Records, Multitasking, Organizational Skills, Outsourcing, Quality Control, Regulations, Regulatory Requirements, Regulatory Submissions, Rehabilitation Nursing, Schedule Development, Standard Operating Procedures (SOP), Support Documentation, Team Lead/Manager, Time Management, Willing to Travel
LOCATION
Lexington, Massachusetts
POSTED
3 days ago
Clinical Document Management Specialist IVA 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.Job DescriptionNOTE:TMF BackgroundPharma Industry experience (couple of years) Clinical Trial Experience (few years) GCP Experience (few years) Not senior level experience (doesn't need a decade worth of experience) Bachelor's degree requiredDay to day Mtg of TMF-early planning and setup all the way to study closeout and performing of consolations and archival activitiesFocusing on TMF lifecycle as a whole TMF assigned specific trials to work on Day to day activities include:QC of documents (paper and electronic)Team meetings (communicating issues to CTA/CRA) FilingJOB DESCRIPTION:Reporting 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.Focusing on inspection readiness, monitors compliance of the TMF and supports preparation of documentation required for regulatory agency inspections and internal audits.Oversees 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.Contributes to assigned Clinical Document Management (CDM) initiatives.RESPONSIBILITIES70% 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.Key contributor and member of the clinical study teamMonitors completeness and quality of the Clinical TMF, including elements outsourced to CROEnsures effective communication and issue escalation internally and with external vendorsOversees consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process.Ensures compilation of CSR appendices in accordance with Shire's process20% Supports inspection readiness for GCDO through periodic quality assessment of clinical records.Ensures clinical records are filed in a timely mannerWith direction from the CDM Manager, prepares clinical records for agency inspection.Supports assigned TMF corrective action plans under direction of Senior CDM/Manager.10%Supports CDM initiatives to enhance efficiencies in document management practicesSupports Managers in training efforts for new personnelQualificationsEDUCATION AND EXPERIENCE REQUIREMENTSMinimum 2 years of pharmaceutical industry experienceRecords management/TMF experienceFamiliarity with various aspects of clinical trials and regulatory submissions. Current awareness of regulatory requirements for clinical trials (ICH/GCP).Associates/Bachelor's degree or equivalent preferredKey Skills, Abilities, and CompetenciesSufficient knowledge of regulatory requirements and ICH-GCP guidelines to support records managementDemonstrated ability to work independently, take initiative, complete tasks to deadlinesRequires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlinesSolid communication skills and strong customer focus with ability to interact in a global, cross functional organizationAbility to communicate effectively with external vendors, including issue escalation, and responding to enquiries and concernsMust be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands.Experience with use of Electronic Document Management SystemsAdvanced computer proficiencyDemonstrated ability to be flexible and to adapt quickly to changeAbility to multi-taskOther Job RequirementsFull driving license and passport requiredDomestic (within country) and some potential international travel possible (10%)Additional InformationThanksWarm regards Avleen Kaur 732-318-6945I'm interested

About the Company

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Integrated Resources, Inc