Total 4 Science / R&D / Research job vacancies in Bandar Bukit Jalil, Kuala Lumpur

開放至吉隆坡、布城、雪蘭莪、關丹、古晉和新山。

• 鼓勵應屆畢業生和護理背景申請

職位摘要（該職位的主要職能）

研究協調員 (SC) 負責在現場進行臨床試驗所需的各種活動，包括試驗啟動活動、持續研究管理以及試驗受試者在臨床試驗過程每個階段的協調。 SC 是試驗受試者和研究申辦者的主要聯繫點。 SC 與首席研究員 (PI) 在試驗規劃和現場試驗實施的以下方面進行合作。他們與 PI 一起，根據研究方案要求、良好臨床實踐 (GCP) 和適用的監管要求，確保患者的安全和所收集資料的完整性。

主要職責

1.負責現場日常營運工作

a) 試驗計劃

• 管理和協調從可行性團隊收到的可行性研究，包括會見有興趣的新的和潛在的調查員。支持並追蹤可行性問卷在時限內的完成情況。
• 為倫理委員會申請提供現場相關文件和資訊。
• 與 CRM 的預算審查委員會 (BRC) 合作支持試驗預算審查。

b) 現場試驗 i) 協調

• 根據協定、標準作業程序 (SOP) 和適用指南執行 PI 委託的任務。
• 透過執行委託的預篩選活動，積極協助尋找可能有資格參加試驗的潛在受試者/健康志願者。
• 安排和管理受試者訪視。根據試驗方案要求在受試者訪視期間協助研究者。
• 充當研究者和其他臨床研究利害關係人（包括CRO/申辦者、監管機構和其他機構）之間的聯絡人，支持現場試驗相關活動，包括申辦者/CRO（例如SIV、SMV、CoV）的現場訪問、適當的審計和檢查。
• 根據試驗方案要求收集、處理和運送生物標本。
• 管理試驗輔助用品，包括管理儲存、補給記錄、分配和維持用品的責任。
• 處理和管理研究產品 (IP)，包括 IP 供應、分配、溫度偏差報告的接收、儲存和記錄以及維護 PI 委託的責任。

ii) 資料收集

• 確保及時準確地完成病例報告表(CRF)/e-CRF 並解決疑問。

iii) 其他

• 指導和支持研究者進行試驗預算的支付流程，包括但不限於支付追蹤器的完成、提交和支付。
• 協助研究人員進行受試者安全管理，包括及時向相關當局報告嚴重不良事件 (SAE)（初始/跟進信函 (FUL)）。
• 在研究者現場檔案 (ISF) 中維護指定試驗的重要文件，並提供記錄以供審查。
• 確保試驗實踐反映臨床試驗的道德和法律標準，包括報告利益衝突。
• 遵守品質管理系統 (QMS) ISO 9001:2015 和反賄賂管理系統 (ABMS) ISO 37001 要求下提供的所有標準作業程序和指南。

2. 其他行政支持

• 從醫院和/或衛星站點更新研究者資料庫、研究者良好臨床實踐 (GCP) 認證清單和可行性日誌。
• 每月更新 CRMx 中的產業資助研究 (ISR) 狀態，包括招募進度、即將進行的新試驗、正在進行的試驗、試驗的結束狀態。
• 向 ARM 通報並更新專案現場任何新的潛在試驗。

3. 根據需要，由 ARM 分配：

• SC 可能需要出差發送、接收或檢索來自外部供應商的生物樣本/報告。
• SC 可能需要出差與外部相關方接觸，以確保審判相關程序得到相應安排。
• 未充分利用的 SC 可能需要從目前地點調動到其他計畫地點，按照研究者的同意並得到臨床營運主管的批准，執行與試驗相關的活動。

基本工作要求

• 科學、聯合健康科學、醫學和護理學位。
• 較強的組織能力。
• 一絲不苟，注重細節。
• 能夠獨立工作並按時完成任務。
• 優秀的溝通（口頭和書面）和人際交往能力。
• 熟練使用標準電腦程序，包括 MS Office 套件。
• 最好是經過 GCP 認證的。
• 展示臨床研究和醫學術語的基本知識。
• 具有研究領域/臨床試驗的經驗。
• 適應不斷變化的工作環境和工作任務。
• 在團隊中工作良好，但自我驅動。

• ISO 9001:2015 和 ISO37001:2016 認證組織
• 每週 5 天工作，有競爭力的福利
• 業務擴張、臨床研究/試驗、職業發展

Open for Kuala Lumpur, Selangor, Seri Manjung, Johor Bahru & Kuching

• Fresh Graduates and Nursing Backgrounds are encouraged to apply

JOB SUMMARY (Major functions of the position)

Study Coordinator (SC) is responsible to perform variety of activities essential to the conduct of clinical trials at the site, including trial start-up activities, ongoing study management and coordination of trial subjects at every stage of their clinical trial journey. SC is the main point of contact for trial subjects and study’s Sponsor. The SC works with Principal Investigator (PI) in the following aspects of trial planning and trial conduct at the site. Together with PI, their work ensures the safety of the patients and the integrity of data collected, in accordance with the study protocol requirements, Good Clinical Practice (GCP) and applicable regulatory requirements.

KEY RESPONSIBILITIES

1. Carry out day-to-day operations at the site level

a) Trial planning

• Manage and coordinate feasibility study received from Feasibility Team, including meeting new and potential Investigators who are interested. To support and follow up the completion of feasibility questionnaires within timelines.
• Provide site-related documents and information for Ethics Committee application.
• Support trial budget review, in association with CRM’s Budget Review Committee (BRC).

b) Trial conduct at site i) Coordination 

• Perform tasks as delegated by PI in accordance with the protocol, Standard Operating Procedures (SOP) and applicable guidelines.
• Proactively assist in finding potential subjects/healthy volunteers who may be eligible to participate in the trial by performing pre-screening activities as delegated. 
• Schedule and manage subject visit. Assist Investigator during subject’s visit in accordance with trial’s protocol requirements.
• Act as liaison between Investigators and other clinical research stakeholders (including CROs/Sponsor, Regulatory Agency and others) to support trial-related activities at site including site visit from Sponsor/CRO (e.g. SIV, SMV, CoV), audits and inspection as appropriate.
• Collect, process and ship biological specimens as per trial’s protocol requirements.
• Manage trial ancillary supplies including managing the storage, record of the resupply, dispensing and maintaining the accountability of the supplies.
• Mandle and manage Investigational Product (IP), including the receival, storage and record of IP supply, dispensing, temperature excursion reporting and maintaining the accountability of IPs as delegated by the PI. 

 ii) Data Collection

• Ensure timely and accurate completion of Case Report Form (CRF)/e-CRF and queries resolution.

iii) Others

• Guide and support Investigators on the payment process of trial budget including but not limited to payment tracker completion, submission, and disbursement.
• Assist Investigators in subject safety management including timely reporting (Initial/Follow Up Letters (FUL)) of Serious Adverse Events (SAEs) to the appropriate authorities. 
• Maintain essential documents in Investigator Site Files (ISF) for assigned trials and make records available for review.
• Ensure trial practices reflect ethical and legal standards for clinical trials, including reporting conflicts of interest.
• Adhere to all Standard Operating Procedures and guidelines provided under the Quality Management System (QMS) ISO 9001:2015 and Anti-Bribery Management System (ABMS) ISO 37001 requirements.

2.Other Administrative support:

• Update Investigator database from hospital and/or satellite sites, Investigator Good Clinical Practice (GCP) certification list and feasibility log.
• Update Industry Sponsored Research (ISR) status including recruitment progress, upcoming new trials, ongoing trials, closure status of the trials in CRMx on monthly basis.
• Inform and update ARM on any new potential trials at project site.

3. As and when required, assigned by ARM:

• SC may need to travel to send, receive or retrieve biological samples/reports from external vendors. 
• SC may need to travel to engage with the external relevant parties to ensure trial related procedures are arranged accordingly.
• Under-utilized SC may need to mobilize from current site to other project sites performing trial related activities as agreed by investigators and approved by Head of Clinical Operations.

BASIC JOB REQUIREMENTS

• Degree in Science, Allied Health Science, Medical and Nursing.
• Strong organizational skills.
• Meticulous, attention to detail.
• Able to work independently to meet deadlines.
• Excellent communication (verbal and written) and interpersonal skills.
• Skilled with standard computer programs including the MS Office suite.
• Preferably GCP-certified.
• Demonstrate basic knowledge of clinical research and medical terminology.
• Have prior experience in research field/clinical trial.
• Adaptability to changing working situations and work assignments.
• Works well in a team but is self-driven.

• Certified ISO 9001:2015 & ISO37001:2016 Organisation
• 5 Day Work Week, Competitive Benefits
• Expansion in Business, Clinical Research/Trials, Career Growth

Job Brief:

The Marketing Executive is responsible for supporting the marketing team in various activities to promote the organization's products and services. This role involves content creation, designing promotional materials, managing social media, assisting in lead generation campaigns, and coordinating physical events.

Job Responsibilities:

• Crafting engaging content, designing banners, and creating social media posts and content.
• Assisting in the creation and management of campaigns to drive leads.
• Developing and implementing marketing strategies to enhance brand awareness.
• Analyzing market trends and competitor activities to identify opportunities for growth.
• Coordinating and participating in the planning and execution of all physical events.
• Monitoring and reporting on the effectiveness of marketing campaigns.
• Collaborating with cross-functional teams to ensure cohesive and impactful marketing efforts.
• Managing the company's online presence and community engagement across various platforms.

Job Requirements:

• Minimum Diploma / Degree in Marketing, Communications and related field.
• Proven experience in marketing.
• Good communication skills in English, Mandarin is a plus.
• Fresh graduates are welcome to apply.
• Adaptable and enjoy working in past paced environment.
• Proficiency in graphic design software (e.g., Adobe Creative Suite).
• Familiarity with social media platforms and content management systems.

Job Brief:

We are looking for a skilled IT Product Manager to lead the development, enhancement, and optimization of our technology products and services. As an IT Product Manager, you will be responsible for the product lifecycle, from ideation and strategy to implementation and performance monitoring. You will work closely with cross-functional teams to ensure the product meets business goals.

Job Responsibilities:

• Gather and prioritize product requirements from stakeholders, defining and developing clear product strategy, specifications and user stories for the development team.
• Work closely with cross-functional teams (e.g., engineering, UX/UI design, marketing) to deliver high-quality products that meet user needs and business goals.
• Serve as the main point of contact for product-related queries, updates, and stakeholder communications throughout the product lifecycle.
• Set and monitor product KPIs (e.g., user engagement, performance, adoption rate, etc.) to assess the success and identify areas for improvement.
• Ensure strong product documentation and maintain accurate records of updates, features, and issues.
• Provide training and product insights to internal teams, equipping them with the knowledge to support customers effectively.
• Identify potential risks and create mitigation strategies, ensuring minimal impact on product performance and timelines.
• Resolve product issues in a timely manner and work with IT and support teams to address and escalate incidents when necessary.

Job Requirements:

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or a related field. 
• 3-5 years of experience in product management, with a focus on IT products or technology solutions.
• Technical Skills:
• Strong understanding of software development processes, IT infrastructure, cloud computing, and cybersecurity.
• Proficiency with product management tools (e.g., JIRA, DevOps) and familiarity with Agile/Scrum methodologies.
• Experience with data analysis and familiarity with tools such as Google Analytics, SQL, or BI software is a plus.
• Proficiency in software development with expertise in Java, Bootstrap, Framework 4.0, jQuery, Visual Basic, HTML, and ASP Classic is a plus.
• Knowledge of application security (encryption, authentication, security assessments) is a plus.
• Soft Skills:
• Excellent communication and interpersonal skills, with the ability to translate technical concepts into user-friendly language.
• Strong problem-solving skills, with a proactive approach to identifying and addressing challenges.
• Ability to work in a fast-paced environment, managing multiple projects and priorities simultaneously.
• Demonstrated interest and passion for the industry.