Senior Clinical Records Specialist with Veeva experience- home-based

Execupharm Uk Limited ,
London, Greater London
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Overview

For our European operations, we are currently looking for a Senior Clinical Records Specialist with Veeva experience. This will be a full-time, permanent role, fully home-based. ExecuPharm (PAREXEL Company) is looking to reward the SCRS with a competitive base salary combined with a benefits package. SCRS will be offered numerous career progression opportunities within the Organisation. Position Purpose: The Sr. Clinical Records Specialist is responsible for activities and systems related to clinical records and considers the operational and business needs of the Trial Master File. Organizational Relationships: · Reports to ExecuPharm (EP) assigned Line Manager with day-to-day direction from the Client. · Liaises with cross functional lines as appropriate. Primary Duties: · Maintenance of Trial Master File (system or file room) which may include the following: o Managing the controlled access process, including access training and monitoring o Managing study file structure process and documentation o Managing record archival and retrieval processes o Scanning documents to support filing electronically o Performing routine document quality control in the electronic file and conducting routine system tasks o Performing training cross-functionally to set expectations for filing in the Trial Master File · Support internal and regulatory audits and inspections by making Trial Master File contents available as needed · Lead Clinical Records projects as assigned, such as (but not limited to): o Records retention, disaster/recovery o Quality reviews of Clinical Records processes to identify issues and implement solutions o Migrating paper-based studies to electronic Trial Master File o Performing Trial Master File oversight in the form of periodic risk-based QC reviews on documents o Participating in the development, implementation, and maintenance of electronic Trial Master File system and/or file room · Primarily works and collaborates with supervisor, peers, and Trial Master File users across departments · Identifies trends and escalates to the Trial Master File System Owner · May determine methods and procedures on new assignments · May participate in system administration, subject matter expert (SME) and ad-hoc meetings to report on status, provide demonstrations of system functionality, and/or gather requirements for new or updated features · Works under general supervision and on assignments that are moderately complex in nature where judgment is required in resolving routine problems and making routine recommendations · Adhere to CFR, GCP/ICH, ALCOACCEA, company policies, Clinical Development Operations and project-specific quality documents (e.g., SOPs, work practices, training guides, defined Trial Master File key performance indicators) · Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training · Adheres to EP and Client SOPs and processes Skills and Education: · BS/BA or equivalent preferred · A minimum of 2 years clinical trial or Trial Master File experience preferred within the pharmaceutical or biotechnology industry · Familiarity with the DIA Trial Master File Reference Model structure · Basic knowledge and understanding of CFR and GCP/ICH · Proficiency with Microsoft Office Products - Word, Excel, PowerPoint, SharePoint, Veeva · Fundamental understanding of filing systems and organizational tools · Strong communication and inter-personal skills · Highly responsive and proactive, a team player · Understanding of GCP principles, their importance, and how they apply to operational activities for this position For an immediate consideration-please contact the job poster. We look forward to hearing from you. This job was originally posted as www.totaljobs.com/job/89769751

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