Kvalito Consulting Group

About Kvalito Consulting Group

Workload: 100% Duration: Temporary: 1-year contract Business Division: Our client’s Trial Management, Clinical Document Governance Management Department Job Purpose: Responsible for the development and implementation of the communication and training campaign on Clinical Documentation including Trial Master File within our client’s organization under the leadership of the TMF Operational Excellence Head. Major Activities · Support the TMF Operational Excellence Head to define the document management training and communication strategy for the Clinical study documentation including the Trial Master File, and the oversight of the process, systems and tools for Headquarters and Country Organizations. · Promote best documentation practice to line functions to ensure that documents created/generated in the course of clinical research are managed and archived in accordance with GCP guidelines and internal SOPs · Develop training material, provide training, coaching of knowledge and experience to enhance the expertise of your colleagues. Support attend and present TMF trainings in multiple forums across different line functions. Collaborate with training teams in different line functions to deliver training as appropriate · Manage the TMF mailbox including addressing questions and liaising with stakeholders as needed. Follow up on responses to ensure closure of the questions. Maintain SharePoint including Question and Answer tracker and identify potential trends. Organize regular Question and Answer sessions on TMF Processes, Systems and tools (eg eTRAC, TMF TOC, VirtualTOC, Document Management System) · Serve as a liaison between process end-users and eDMS / TMF Governance and Management teams to drive user needs assessment workshops, technical solution discussions and implementation plan. Ensure best practice sharing and promote awareness. Pro-actively provide end-user solutions · As TMF Operational Excellence representative, you may participate in global cross-functional business process performance or clinical development improvement initiatives. · Continuously seek room for improvement on existing training concepts and material, and initiate and lead improvement initiatives Ideal Profile Education: Bachelor’s degree required; Advanced degree in life science preferred with minimum 5 years’ experience in clinical operations and/or clinical document management. Languages: Fluentwritten and spoken English. Additional languages desirable Experience /Professional Requirements: Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice. Advanced ability to work both independently and in a global cross-functional multicultural and international teams. Excellent understanding of system data structures and Clinical Document Management System functionality Ability to learn new systems with enthusiasm. Strong computer skills (EXCEL, MS Word) required Excellent attention to accuracy and details Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines. Proven networking skills and ability to train colleagues. Strong interpersonal skills. Ability to work under pressure Resolve issues with minimal supervision and understand when to escalate We offer great benefits Flat hierarchies and responsibility from the beginning People-oriented culture Diversity and inclusion-focused environment Global client projects in a multinational environment Involvement in global conferences Individual professional development, training and coaching Contact If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send us your application including: CV Letter of Motivation Salary requirements Availability/earliest start date We are looking forward to receiving your application. Your KVALITO Team. Job Types: Full-time, Temporary

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