Clinical Operations

  • location: Lexington, MA
  • type: Contract
  • salary: $22.54 - $26.52 per hour

job description

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Clinical Document Management Specialist II

Job Summary

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.

Job Responsibilities

70% of Responsibilities

  • 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 process

20% of Responsibilities

  • 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% of Responsibilities

  • Supports CDM initiatives to enhance efficiencies in document management practices
  • Supports Managers in training efforts for new personnel

Education & Qualifications

  • Associates/Bachelor's degree or equivalent preferred
  • 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).Sufficient knowledge of regulatory requirements and ICH-GCP guidelines to support records management
  • Demonstrated ability to work independently, take initiative, complete tasks to deadlines
  • Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines
  • Solid communication skills and strong customer focus with ability to interact in a global, cross functional organization
  • Ability to communicate effectively with external vendors, including issue escalation, and responding to inquiries and concerns
  • Must 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 Systems
  • Advanced computer proficiency
  • Demonstrated ability to be flexible and to adapt quickly to change
  • Ability to multi-task
  • Full driving license and passport required
  • Domestic (within country) and some potential international travel possible (10%)


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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