シミックホールディングス株式会社／CMIC HOLDINGS Co., Ltd. (HQ) Overseas Jobs- Asia and US の求人一覧
全 175 件中 6 件 を表示しています
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Clinical Research Associate (CRA) ※Hong Kong
This is a home-based full-time position in Hong Kong Office. POSITION PURPOSE: To support project(s) as ICH E6 GCP definition of "Monitor" To ensure all designated clinical/site monitoring activities are conducted in highest quality standards To conduct project with CRA role in the project activity as required Support in operations and/or business's continuality by undertaking tasks such as: Mentoring and training of new employees as required Support business development activities Review, revise and/or develop clinical operations service related work guides or site specific documents ...etc. RESPONSIBILITIES: Responsible for performing all monitoring aspects of clinical trials and assist to set up, review and maintain project files to ensure compliance as stated in ICH E6 GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring an close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards Planning, develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers include initial/amendment/interim report/safety reporting to regulatory and/or ethics committee for review and follow up until approval, as required Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required Manage/support project(s) in the capacity of CRA role and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company Support/Assist in Site and CRO audit or inspection as required Support business development activities (e.g. search new project related information) as required Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration Proactively identify and facilitate resolution of complex study problems and issues. Actively work towards achieving good personal relationships with the project Team members REQUIREMENTS: Qualifications Minimum 2 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or is a qualified pharmacist or medical doctor by training with no previous experience in relevant experience in clinical research Preferably has experienced in clinical study monitoring Experience and Skills Good knowledge of medical terminology and clinical/medical practices Basic understanding of cross-functional processes, clinical trial processes and regulatory environment Good computer/technology skills including MS Word, MS Excel, PowerPoint etc. Effective written and verbal communication skills, preferably with good command of English in addition to local language Good team player with excellent interpersonal and organization skills Possess advanced monitoring skills Application: Interested parties please apply via LinkedIn https://www.linkedin.com/jobs/cap/view/2159733761/?pathWildcard=2159733761&trk=mcm 続きを見る
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Clinical Research Associate ※Australia
This is a home-based full-time position in Australia office. POSITION PURPOSE: To support project(s) as ICH E6 GCP definition of "Monitor" To ensure all designated clinical/site monitoring activities are conducted in highest quality standards To conduct project with CRA role in the project activity as required Support in operations and/or business's continuality by undertaking tasks such as: Mentoring and training of new employees as required Support business development activities Review, revise and/or develop clinical operations service related work guides or site specific documents ...etc. RESPONSIBILITIES: Responsible for performing all monitoring aspects of clinical trials and assist to set up, review and maintain project files to ensure compliance as stated in ICH E6 GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring an close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards Planning, develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents Develop, compile and/or submit dossiers include initial/amendment/interim report/safety reporting to regulatory and/or ethics committee for review and follow up until approval, as required Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required Manage/support project(s) in the capacity of CRA role and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company Support/Assist in Site and CRO audit or inspection as required Support business development activities (e.g. search new project related information) as required Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration Proactively identify and facilitate resolution of complex study problems and issues. Actively work towards achieving good personal relationships with the project Team members REQUIREMENTS: Qualifications Minimum 2 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or is a qualified pharmacist or medical doctor by training with no previous experience in relevant experience in clinical research Preferably has experienced in clinical study monitoring Experience and Skills Good knowledge of medical terminology and clinical/medical practices Basic understanding of cross-functional processes, clinical trial processes and regulatory environment Good computer/technology skills including MS Word, MS Excel, PowerPoint etc. Effective written and verbal communication skills, preferably with good command of English in addition to local language Good team player with excellent interpersonal and organization skills Possess advanced monitoring skills Application: Interested parties please apply via LinkedIn https://www.linkedin.com/jobs/cap/view/2159733761/?pathWildcard=2159733761&trk=mcm 続きを見る
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Associate Director/Large Molecule Group ※CMIC, Inc.
POSITION PURPOSE: The Associate Director/Large Molecule is responsible for leading the large molecule teams for successful study execution and meeting laboratory overall objectives and timelines. Actively participates in business discussions, service promotions, and new service creation Will serve as a Principal Investigator (PI); managing a team of analysts and achieving unit objectives within time constraints by successfully managing and conducting multiple study initiations, executions and completions within designated timelines and budget, and meeting company quality standards. Effectively communicate with clients; present experimental results to internal and external clients. Document work and maintain study documentation and lab records. RESPONSIBILITIES: • Ensure GxP (when applicable) and 21 CFR part 11 compliance for Bioanalysis. • Ensure CMIC internal procedures and policies are properly followed by your team members • Ability to assume PI role in accordance with GxP requirements and participate in lab activities. • Proficient communication skills with sponsors, lab staffs, QA and officers. • Must effectively manage the timelines for his/her groups, and achieve project objectives within time constraints • Act of a subject matter expect. Troubleshoot, recommend alternative methods of solving a problem and develop solutions to problems. • Manage, mentor and coach a team of analysts. Build and maintain a cohesive team. • Lead lab improvement including operation efficiency. • Effective time management, organization, and teamwork skills as well as attention to detail with the ability to multitask. • Responsible for confidential and time sensitive material. • Recommend and develop technology innovation. Assist with new service creation. • Assumes other activities and responsibilities as assigned. REQUIREMENTS: Qualifications 7+ years working in a GLP Bioanalysis laboratory environment performing timely study management from bioanalysis sample processing, validation, and conducting and troubleshooting pre-study work independently with Instrument hands-on experience of ECL - MSD S600, ELISA – absorbance, fluorescence, luminescence; qPCR – Quant Studio 5; and or Cytoflex – Flow Cytometer for large molecule. Management Duties. M.S. in related field or Equivalent. PhD preferred. Experience and Skills Proficient in method development, method validation, bio-sample preparation and study sample analysis. ・ELISA – absorbance, fluorescence, luminescence ・ECL - MSD S600 ・qPCR – Quant Studio 5 ・Cytoflex – Flow Cytometer ・Proficient troubleshooting skills. ・Maintain quality execution and work. ・Demonstrated effective oral and written communication skills. ・Staff, team management with the ability to mentor, coach and build analysts skillsets ・Effective time management skills; complete unit goals in a timely manner and within allotted budget. (i.e. maintain timelines). ・Manage lab equipment usage and maintain lab equipment appropriately for assigned tasks. ・Understand and mentor GxP requirements, SOP/SWPs and related lab procedures; safety policies and company policies. ・Ability to proactively prevent non-compliant issues in lab operations. ・Ability to handle confidential information. ・Proficient presentation skills. ・Proficient in MS Office and to be adept at learning new systems APPLICATION: Application method Interested parties please apply via HR@cmicgroup.com Responsible Person Contact details Name: Denise Washick Email: Denise-Washick@cmicgroup.com 続きを見る
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Research Analyst【CMIC, Inc.】
POSITION PURPOSE: The Research Analyst will perform lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 as directed from Group Leader and Sr. Analysts. Conduct Bio-analysis validation, sample analysis, and Pre-Study work. Utilize establish techniques to compile and analyze data. Document work and maintain study documentation and lab records. Perform other routine laboratory duties as deemed necessary RESPONSIBILITIES: • Understand and comply with GLP requirements and follow Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies. • Use and properly maintain lab instrument and equipment appropriately for assigned tasks. • Conduct Bio-analysis validation and sample analysis. • Conduct pre-study/method development as needed. • Assist Group Leader with Plan and Report preparation when needed. • Maintain accurate records of work and study documentation per GLP Good Documentation Practices and per company SOPs. • Maintain proprietary and confidential information. • Assumes other activities and responsibilities as assigned. REQUIREMENTS: Qualifications Preferred 1+ years working in a GLP Bioanalysis laboratory environment performing bioanalysis sample processing/analysis and validation independently with instrument hands-on experience of instrumentation ・Small Molecule: LC-MS/MS and/or UHPLC-UV; UHPLC-FD. ・Large Molecule: ECL - MSD S600, ELISA; ; qPCR – Quant Studio 5; and or Cytoflex – Flow Cytometer B.S. or M/S. in related field, Experience and Skills • Understand GLP requirements, SOP/SWPs and related lab procedures; safety policies and company policies. • Use and maintain lab equipment appropriately for assigned tasks. • Utilize scientific theory with proper skills • Maintain quality execution and work. • Ability to handle confidential information. • Demonstrated effective oral and written communication skills. • Good team player. • Effective time management skills; complete work in a timely manner (i.e. maintain timelines). • Proficient in MS Office and to be adept at learning new systems. APPLICATION: Interested parties please apply via HR@cmicgroup.com Responsible Person Contact details Name: Denise Washick Email: Denise-Washick@cmicgroup.com 続きを見る
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Corp. Marketing Inside Sales Associate ※US Office
POSITION PURPOSE: The Field Marketing Associate/Inside Sales Associate role is responsible for developing meaningful relationships with potential and current customers to encourage trust and loyalty with the CMIC brand. This role will be responsible for gaining new marketing leads, nurturing leads and passing on marketing qualified leads (MQL) to the BD groups. The inside sales associate will communicate and support both the marketing and sales teams to continue to build a strong CMIC corporate brand within the US, promoting CMIC Pharmaceutical Value Creator (PVC) model, and CMIC CRO and CDMO business offerings to global clients and prospects. This position will report directly to US Marketing Manager, Corporate Marketing Department. RESPONSIBILITIES: Support Business Marketing team and major marketing campaigns with targeted customer prospecting using business intelligent database Follow-up on marketing campaign leads to qualify and work leads down the sales funnel Understand and demonstrate CMIC services to the customers Sourcing new customer prospects through inbound lead follow-up (including web inquires) and outbound cold calls/emails Meet sales goals and objectives Thorough understanding of customer needs and requirements Routing qualified leads to the appropriate sales teams for further development/closure Develop relationships and help monitor and profile key account customers Maintain database of current and potential customers Assumes other activities and responsibilities as assigned REQUIREMENTS: Qualification Education or Equivalent: Bachelor (required), with business, communication or life science focus 2+ years’ prior experiences in field sales - or inside sales 2+ years’ experiences in life sciences, pharmaceutical or related healthcare industries, with pharmaceuticals and/or B2B, or contract service background preferred Experience and Skills Possesses a unique blend of business/marketing and technical savvy Have strong communication, negotiating, and time management skills Experience in Salesforce as a CRM system for sales and marketing execution Experience in a call center, customer support role a plus Inbound/outbound sales expertise Marketing campaign/lead management support Demonstrated success in working with various sales teams Strong problem solving, analytical and project management skills Highly proficient in PowerPoint and Excel for presentation and data analysis Strong written and verbal communication skills, strong inter-personal development skills APPLICATION: Interested parties please send your application via email to HR@cmicgroup.co 続きを見る
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Group Leader ※US Office
POSITION PURPOSE: The Group Leader (C-1) is an inspiration to the group, motivating and leading group activities and functions. In this role, you are responsible for leading and performing laboratory activities in accordance with applicable Methods, Plans, SOPs/SWPs, GxP regulatory guidelines and 21 CFR Part 11 independently. You will serve as a Principal Investigator (PI); managing a team of analysts and achieving unit objectives within time constraints by successfully managing and conducting multiple study initiations, executions and completions within designated client timelines and budget, meeting company quality standards. You are expected to recommend alternative methods for solving a problem. Effectively communicate with clients; present experimental results to internal and external clients. Document work and maintain study documentation and lab records. Maintain effective daily lab operations including providing direction, mentoring and coaching to lesser-skilled teams of analysts to build skillsets. You will participate in the quotation process, SOP and other technical related document preparation and training; participate in marketing efforts, publications, presentations and posters. RESPONSIBILITIES: Comply and mentor a team of analysts with GLP requirements, Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies. Serve as a Principal Investigator (PI) successfully managing and conducting multiple study initiations, executions and completions within the time constraints while still maintaining the quality standards of the company. Ability to present experimental results during group, team and management meetings. Provide written summaries of work for presentation to clients and communicate directly with clients. Manage, mentor and coach a team of analysts. Build and maintain a cohesive team. Perform evaluations and set goals; ensure unit goals are being met. Address performance related concerns. Act of a subject matter expect. Troubleshoot, recommend alternative methods of solving a problem and develop solutions to problems. Actively participate in lab improvement including operation efficiency. Participate in the quotation process; audit process; audit visits; client visits. Professional communication (both oral and written) with clients and management. May participate in interview process. Effective time management, organization, and teamwork skills as well as attention to detail with the ability to multitask. Responsible for confidential and time sensitive material. Participate in marketing efforts through publications, presentations, posters. Assumes other activities and responsibilities as assigned. REQUIREMENTS: Qualifications: 5 years working in a GLP Bioanalysis laboratory environment performing timely study management from bioanalysis sample processing, validation, and conducting and troubleshooting pre-study work independently with instrument hands-on experience of LC-MS/MS and/or UHPLC-UV; UHPLC-FD for small molecule. Supervisory duties M.S. in related field or Equivalent. PhD preferred. Experience and skills: Proficient in method development, method validation, bio-sample preparation and study sample analysis. LC-MS/MS (SM) UHPLC-UV (SM) UHPLC-FD (SM) Proficient troubleshooting skills. Maintain quality execution and work. Demonstrated effective oral and written communication skills. Staff, team management with the ability to mentor, coach and build analysts skillsets Effective time management skills; complete unit goals in a timely manner and within allotted budget. (i.e. maintain timelines). Manage lab equipment usage and maintain lab equipment appropriately for assigned tasks. Understand and mentor GxP requirements, SOP/SWPs and related lab procedures; safety policies and company policies. Ability to proactively prevent non-compliant issues in lab operations. Ability to handle confidential information. Proficient presentation skills. Proficient in MS Office and to be adept at learning new systems. APPLICATIONS: Application method Interested parties please apply via HR@cmicgroup.com Responsible Person Contact details Name: Denise Washick Email: Denise-Washick@cmicgroup.com 続きを見る
全 175 件中 6 件 を表示しています