Clinical Document Management Specialist

Clinical Document Management SpecialistIntegrated 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 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.ResponsibilitiesKey contributor and member of the clinical study team

Monitors completeness and quality of the Clinical TMF, including elements outsourced to CROEnsures 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

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.Supports CDM initiatives to enhance efficiencies in document management practices

Supports Managers in training efforts for new personnel

QualificationsEducation and Experience RequirementsMinimum 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 CompetenciesSufficient 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 SystemsAdvanced computer proficiency

Demonstrated ability to be flexible and to adapt quickly to change

Ability to multi-taskInternal and External ContactsInternal study team members within the R&D organization at various levels, global team colleagues; external vendors (CROs, other service providers)Other Job RequirementsFull driving license and passport required

Domestic (within country) and some potential international travel possible (10%)Kind Regards ,Sasha SharmaClinical RecruiterIntegrated Resources, Inc.IT Life Sciences Allied Healthcare CRODIRECT # - 732-662-7964