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Clinical Document Management Specialist

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Biotech and Pharmaceutical, Clinical Data Management, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Corporate Compliance, Corrective Action, Document Management, GCP (Good Clinical Practices), Healthcare Quality, ICH Regulations, Information Technology & Information Systems, Internal Audit, Maintain Compliance, Medical Records, Outsourcing, Quality Monitoring, Records Management, Regulations, Regulatory Requirements, Regulatory Submissions, Rehabilitation Nursing, Standard Operating Procedures (SOP), Support Documentation, Team Lead/Manager, Time Management
LOCATION
Lexington, Massachusetts
POSTED
2 days ago
Clinical Document Management SpecialistA 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.This is a contract position with my direct client.Job DescriptionReporting 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 team• Monitors completeness and quality of the Clinical TMF, including elements outsourced to CRO• Ensures effective communication and issue escalation internally and with external vendors• Oversees 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 manner• With 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 practicesQualificationsEducation and Experience Requirements• Minimum 2 years of pharmaceutical industry experience• Records management/TMF experience• Familiarity 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 preferred

About the Company

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Integrated Resources, Inc