Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functi…
Skills: Administrative Support, Trial Master File (TMF) Management, Clinical Documentation, Microsoft Word, Microsoft Excel
Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
Company:Oliver Wyman Description: About Oliver Wyman Oliver Wyman is a global leader in management consulting. With offices in 70 cities across 30 countries, Oliver Wyman combines deep industry knowledge with specialized…
Skills: Secondary Research, Data Synthesis, Bloomberg, LSEG-Eikon-Refinitiv, S&P Capital IQ
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
The Medical Affairs team collaborates with the leaders of Sleep, Respiratory Care, SaaS, ResMed Healthcare, and Asia Growth Markets to ensure our work, especially our clinical research and market access projects, align w…
Skills: Clinical Accuracy Review, Knowledge Management, Literature Searches, Medical Writing, Scientific Evidence Appraisal
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
The team Global Strategic Insights Center (GSIC) provides secondary research and analysis services to global Deloitte member firms supporting pursuit, business development, practice development, and client engagements. T…
Skills: Secondary Research, Financial Analysis, Business Writing, Storyboarding, Data Visualization
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
1. Assist in compiling and analysing the SWAP database to ensure accurate compilation for technical evaluation and management reporting. 2. Assist in the identification and screening of P&A candidates through analysis of…
Skills: Data Analysis, Technical Evaluation, Well Integrity Analysis, Digital Dashboard Development, Reporting
Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
At Materialise Medical, we believe that better healthcare starts with solutions designed around the individual patient. If you’re passionate about bringing personalized care to every patient, you’ll love being a part of …
Skills: 3D Virtual surgery planning, Medical imaging, CAD, Biomedical engineering, Anatomy
Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
About Gen Gen is a global company dedicated to powering Digital Freedom through its trusted consumer brands including Norton, Avast, LifeLock, MoneyLion and more. Our combined heritage is rooted in financial empowerment …
Skills: Machine Learning, Predictive Analytics, Statistical Modeling, A/B Testing, Python
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Pall Corporation, one of Danaher’s 15+ operating companies, our work saves…
Skills: Order Management, Customer Service, Microsoft Office, ERP, SAP S4H
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
1. To work on overall Focused Group Performance Excellence initiatives. 2. To support well department events 3. To work on studies related to drilling.
Skills: Research, Data Capture, Minute Taking, Drilling Studies, Performance Excellence
Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
About Gen Gen is a global company dedicated to powering Digital Freedom through its trusted consumer brands including Norton, Avast, LifeLock, MoneyLion and more. Our combined heritage is rooted in financial empowerment …
Skills: Generative AI, Retrieval-Augmented Generation (RAG), Agentic Workflows, AI Orchestration, Model Evaluation
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
As an Associate Consultant at IQVIA, your problem-solving, analytical, critical thinking and leadership skills will be called upon from day one. You will be responsible for the delivery of consulting projects. An Associa…
Skills: Problem Solving, Analytical Thinking, Critical Thinking, Leadership, Market Research
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
GENERAL DESCRIPTION Licensed professional authorized by law to dispense drugs and medicines prescribed by consultants or other registered medical personnel. Responsible for coordinating and overseeing all pharmacy activi…
Skills: Operational Management, Medication Dispensing, Clinical Pharmacy, Inventory Management, Patient Counseling
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
1) Assist on creating the Solid Control Equipment Enhancement and monitoring checklist and playbook. 2) Data gathering for losses event in the offset wells.
Skills: Data Gathering, Research, Minute Taking, Monitoring, Documentation
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
We are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. …
Skills: Python, Git, C#, F#, JavaScript
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
We are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. …
Skills: Python, Git, C#, F#, JavaScript
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
We are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and their careers. …
Skills: Python, Reservoir Engineering, Software Engineering, Git, C#
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
As a Consultant at IQVIA, you will be responsible for the development & delivery of consulting projects. You will also be part of the regional consulting group and will have the opportunity to support larger & more compl…
Skills: Analytical Skills, Problem-solving, Project Management, Client Relationship Building, Executive Presence
Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
CRA II - Malaysia ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, coll…
Skills: Clinical Trial Monitoring, Site Qualification, Protocol Compliance, Data Integrity, Patient Safety
Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
Overview At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our cur…
Skills: Consultative Selling, Strategic Account Planning, Business Acumen, CRM, Tender Management
Kuala Lumpur, Kuala Lumpur, Malaysia · On-site
By joining Sedgwick, you'll be part of something truly meaningful. It’s what our 33,000 colleagues do every day for people around the world who are facing the unexpected. We invite you to grow your career with us, experi…
Skills: Python, R, SQL, Machine Learning, Statistical Modelling
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The role involves performing daily administrative activities to ensure the accuracy and completeness of the Trial Master File. Key duties include maintaining clinical documents, managing trial supplies, and tracking Case Report Forms and clinical data flow.
Candidates must have a high school diploma and 3 years of administrative support experience. Proficiency in Microsoft Office and knowledge of GCP and ICH guidelines are required.
Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Assist with periodic review of study files for completeness.
Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
High School Diploma or equivalent
3 years administrative support experience.
Equivalent combination of education, training and experience.
Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
Written and verbal communication skills including good command of English language.
Effective time management and organizational skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
Knowledge of applicable protocol requirements as provided in company training.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US
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