We are seeking a Clinical Operations Coordinator to oversee the planning and execution of clinical studies in compliance with GCP/ICH guidelines and company SOPs. This role serves as the primary contact for clinical trial operations and manages day-to-day activities to ensure successful study completion.
1.. Study Oversight & Compliance
- Lead planning, execution, and management of clinical studies.
- Ensure compliance with GCP/ICH guidelines, applicable regulations, and company SOPs.
- Act as the primary point of contact for all clinical trial operational activities.
2.. Team Leadership & Coordination
- Manage day-to-day activities of the clinical operations team.
- Provide guidance and oversight to ensure timelines, budgets, resources, and quality standards are met.
3.. Cross-Functional Collaboration
- Work closely with clinical project managers, medical monitors, pharmacokinetics, data management, regulatory affairs, and pharmacovigilance teams.
- Ensure efficient and effective study conduct through cross-functional alignment.
4.. Stakeholder Communication
- Communicate study progress to internal and external stakeholders.
- Identify and mitigate study risks and issues proactively.
5.. Site & Vendor Management
- Oversee investigational sites and third-party vendors to ensure high-quality execution.
6.. Documentation & Systems
- Ensure clinical project-related documents and systems are developed and maintained to high standards.
PRIMARY FUNCTION/OBJECTIVE:
Working with the CoolSculpting Sales Team, National Sales Manager, Marketing Manager, and Account Management Manager to contribute to the sales performance for the CoolSculpting range of products through the delivery of quality marketing strategies and effective program implementation.
CORE JOB RESPONSIBILITIES:
• Responsibilities for all aspects of customer relationship management in the assigned territory – including CoolSculpting® marketing integration
• Achieving sales quota results in the assigned territory. Responsible for performing effective territory penetration, coverage and account identification to drive sales and increase the customer base for the Company’s consumables
• Complete the Annual sales target of devices quantities & sales amount target in assigned territory (existing & new listing customers)
• Providing training, presentations and demonstrations (non-patient) to the customer on application and the safe and effective use of the company’s products using effective communication
• Educating the customer regarding the indications, contraindications, and safety of Company products
• Supporting and helping to facilitate the execution of regional training workshops and tradeshows within the territory and area (including CSE)
• Collaborate brand activities execution, marketing plan with product manager to ensure customer success
• Collect customer feedback, market trends, competitive updates as materials for strategic plan
CerbACT Asia provides testing services for both global and local clinical trials. As a perspective member of the Flow Cytometry Department, you are expected to perform routine flow cytometry testing, PBMC isolation, and cell culture, as applicable. You are also responsible for the maintenance of flow cytometers, cell counters, and other related instruments and equipment. You will be working under regulations of the College of American Pathologists (the CAP) and guidelines of the Good Clinical Laboratory Practices (the GCLP) under supervision of Scientist and Department Head.
As a member of our team, you will have the opportunity to collaborate with our partner labs in the EU and the US. You will participate in assay transfer validations for cutting-edge flow cytometric assays, fostering your professional development.
Responsibilities:
- Perform routine lab testing including flow cytometry, PBMC isolation, whole blood pelleting, (ultra)centrifugation, and cell culture, as applicable.
- Maintain test results and all related records.
- Analyze flow cytometry test results and draft test reports, as applicable.
- Schedule maintenance of lab instruments.
- Perform incoming material QC of antibodies, including inter-lot and inter-shipment comparisons.
- Assist in maintaining adequate laboratory supplies.
- Document all tasks performed according to company’s Quality Management System (QMS) and policies.
- Participate in regular meetings and discussions and present data internally.
- Revise SOPs to improve the workflow.
- Any other department tasks assigned by supervisor.
CerbACT Asia 為全球和台灣當地臨床試驗提供測試服務。 作為流式細胞技術部門的正式成員,您需要執行常規流式細胞儀測試、PBMC 分離和細胞培養(如果適用)。 您也負責流式細胞儀、細胞計數器以及其他相關儀器和設備的維護。 您將在研究員和部門主管的監督下,按照美國病理學家學會 (CAP) 的規定和優良臨床實驗室規範 (GCLP) 的指南之下進行工作。
作為我們團隊的一員,您有機會與我們在歐盟和美國的合作夥伴實驗室合作。 您將參與尖端流式細胞儀檢測的檢測轉移驗證,以促進您的專業發展。
Work with third party (MOC, Marketing Operation Center) to complete product requested jobs (including Veeva email, Mass email, video, eDetails, Web pages, Print, Webinar Content) in content lab. (60%)
Work with Commercial and MOC team to complete required marketing ankle and reference in content lab. (20%)
Assist in communicating and tracking jobs delivery on time (ex: Be able to communicate with contact parts based on planned schedule and actions) (20%)