Company Description
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job 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.
Responsibilities
% of Time Job Function and Description
70% 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% 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 practices
Supports Managers in training efforts for new personnel
Qualifications
Education 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
Key Skills, Abilities, and Competencies
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 enquiries 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
Additional Information
With Regards,
Devin Sharma
732-662-4561
Clinical Recruiter
Integrated Resources, Inc.