Posted in Accounting 4 days ago.
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Location: Raleigh, North Carolina
Pharmaceutical Research Associates, Inc.
(All) | US-NJ
The Clinical Portfolio Specialist (CPS), Business Intelligence & Data Governance is accountable for the overall quality, completeness and timely processing of core regulatory documents, the overall electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) from Site Selection until Site Close. Drive optimization of efficiency to reduce study start-up time, ensure audit-ready eTMF preparedness and compliance with regulations. Timely delivery of high quality regulatory documents in accordance with timelines and compliance to internal standards and external GCP/ICH guidelines and FDA regulations.
•Manage the release, follow-up and tracking of the Full Regulatory Package (FPP), Amendments, Investigator Brochures, and Informed Consents etc.; that are required to initiative the site and/or require an IRB Approval. Work directly with Central IRB to acquire EC approval for Final Protocol, Amendments, ICFs, and Patient Diaries/Questionnaires, etc.
•Manage Clinical Trial Management System (CTMS) data entry and regulatory document management lifecycle of Trial Master File (TMF) study documents at the country, site and patient level with strict adherence to ICH, GCP and FDA regulations as applicable
•As knowledge expert of data and systems, provide support to both the Field Monitoring and Project Management Organizations, pertinent to the administration of CTMS and TMF data, quality, distribution and reporting. Such as
o Provide trial site setup and personnel updates in global clinical planning and tracking database (IMPACT)
o Track screening activities, create and maintain the Master Investigator lists for all clinical trials during the entire site selection and approval process
o Generate performance metrics for potential Investigators and study start up average time for sites
o Provide IMPACT support for Clinical Research Associates, Regional Associate Directors, and Clinical Study Managers to address questions/problems on host system
o Run reports on a regular basis; analyzing and solving issues that would prevent timely roll-up of milestone event dates for the US
•Assist in maintaining TMF (hard and electronic versions), Safety Notifications, Amendments and site personnel contact information within the scope of processing/scanning, quality review and compliance, archiving and tracking. Raise alerts where current status of data quality or performance is at risk to noncompliance
•Assist in managing the quality and compliance of CTMS and TMF through use of reports/tools including CREDI, SharePoint, CTMS, site nomination tools, performance metric tool, and dashboards. Perform periodic regulatory document QC and reconciliation activities of CREDI, to ensure document quality (legibility, naming conventions etc.) standards are maintained for Novartis eTMF documents
•Serve as the primary point of contact/liaison with Field Monitoring Operations, and global Drug Regulatory Affairs (DRA); pertinent to the administration of VDR/RDR and eTMF setup during study start-up and changes to Principal Investigator or 1572
•Support production of comprehensive business reports, data extracts and tools to improve and maintain CTMS data quality and operations performance utilizing Excel, PowerPoint, graphing and systems skills
•Support IT and web-based system (SharePoint) projects around automation of reports or development of tools to aid/drive process improvement as appropriate
•Perform extra assignments beyond assigned regular responsibilities as assigned by Manager
Bachelor's degree, preferably in a life science, mathematics/statistics, computer science/information technology preferred
Languages:Fluent English (oral and written)
1-3 years' experience or equivalent competencies in clinical research including a working knowledge of clinical/regulatory development process; study start-up experience preferred
Knowledge of GCP/ICH guidelines and FDA regulations related to regulatory document collection
Good understanding of TMF document types and the ability to distinguish and segment these documents,
Experience with document management repository systems including workflows, scanning and imaging
Proven strong Microsoft Office skills (i.e. Excel, PowerPoint)
Proven ability to meet timelines and manage work independently by working unilaterally or within teams
Detail oriented with superior organization and documentation skills
Knowledge of Process Improvement Methodology preferred.
Ability to multi-task and prioritize multiple high-priority projects
Strong capability in working in a matrixed environment
Provide excellent communication and interpersonal skills/experience with strong customer service orientation.
Skills & Knowledge:
Strong interpersonal, negotiation and conflict resolution skills
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.