เงื่อนไขการค้นหา

ทักษะ:

Product Development, Business Development, English

ประเภทงาน:

งานประจำ

• Direct report to the Vice President and will be responsible for in total 3 employees.
• The role is cross-functional and international. Work closely with sales, engineering and operations to ensure effective delivery and support for products. Furthermore, the position requires an internal focus on the international board of directors and country organizations.
• Synthesizing various ideas on strategy, planning, building consensus and driving exe ...
• Expected to own the product roadmaps and specifications of product requirements for the entire product portfolio with the Southeast Asian and Oceania management team, HQ and Country organizations. Process and link the information to the Global product development & marketing roadmap.
• Overseeing the ongoing assessment of product development, innovation and improvement of the business's product in a way that the product is constantly growing to suit the customer needs, technology trends, competitive positioning and Southeast Asian and Oceanian market requirements. Ensure that necessary steps are being taken to make any modifications that are being made in the product or strategy in order to bring out the best results for the business.
• Creating a New Product Innovation (NPI) process and oversees on-going development of the product vision and strategy for the region. Spearheading investigation and analyses on the product and the product market.
• Strong sustainable task on influencing business and industry practices by driving innovative ideas, environmentally friendly solutions, energy efficient technologies and products by effective leadership and decisive action.
• Skills And Qualifications A minimum of a master's degree in Engineering preferably supplemented with a Marketing degree or an equivalent in working experience.
• Minimum of 15 years' experience in a senior international commercial development role within a technical/mechanical building engineering environment (network) with preferably HVAC knowledge.
• Someone with a passion for engineering and is used to consultative marketing, knows what is important and is technical achievable to create an ideal situation for the customer.
• Who can demonstrate a high level of analytical and quantitative skills. He should possess the ability to use information/data and various metrics to develop a clear and informative business case.
• Someone who is used to work within complex matrix and international environments.
• Someone who has vision of the building/installation/HVAC market, is used to look ahead.
• Who takes responsibility for his actions and knows how to enthuse his team and country heads.
• A qualified candidate demonstrates strong leadership skills with an ability to convince the team and peers.
• An organized, effective and positive people manager who has proven experience in coaching and managing multicultural teams;.
• Excellent communication skills are a necessity for this position. The position is a supervisory role and communication must be effective towards the team and also towards the international HQ in Korea and several local countries organizations.
• As a person he/she must be empathetic, persuasive, a real go-getter, confident, creative and a strong representative of the presales and business development team within the internal organization and also towards the external contact persons.
• An excellent knowledge (speaking and writing) of the English language is mandatory and preferably any additional language.
• Frequently travelling within Southeast Asia & Oceania (30%).
• Skills and Qualifications

ประสบการณ์:

ไม่จำเป็นต้องมีประสบการณ์ทำงาน

ทักษะ:

English

ประเภทงาน:

งานประจำ

• Contract: 3 Month.
• ขอบเขตการทำงาน .
• ทำรายงานตามที่ผู้ว่าจ้างกำหนด เช่น Daily report, Monthly report, Incident Report.
• ตรวจสอบการทำงานของระบบต่างๆ ในรูปแบบ Routine check, Realtime monitor.
• ตรวจสอบและแก้ไขปัญหาต่าง ๆ ตามคู่มือหรือวิธีการที่ผู้ว่าจ้างกำหนด.
• ติดตั้ง และรื้อถอน อุปกรณ์เพื่อให้บริการ Internet หรือ Wifi ให้แก่ลูกค้าที่มาเช่าใช้บริการ รวมถึงคอยตรวจสอบและให้คำปรึกษาในการใช้บริการ.
• ประสานงานกับลูกค้า เพื่อออกแบบงานบริการต่างๆ และติดตั้ง พร้อมส่งมอบบริการกับลูกค้า.
• งานอื่นๆตามที่ผู้ว่าจ้างกำหนด ตามความเหมาะสม.
• ในกรณีที่ทรัพย์สินของผู้ว่าจ้าง หรือทรัพย์สินในสถานที่ทำงานที่เกี่ยวข้อง ที่ผู้รับจ้างมีหน้าที่ดูแลรับผิดชอบได้รับความเสียหายถูกทำลาย สูญหายในระหว่างปฏิบัติหน้าที่ โดยความประมาทเลินเล่อของผู้รับจ้าง หรือ ในกรณีที่ผู้รับจ้างปฏิบัติหน้าที่ด้วยความประมาท ผู้รับจ้างจะต้องรับผิดชอบต่อเหตุการณ์และชดใช้ความเสียหายต่างๆ ที่เกิดขึ้นในทุกกรณี.
• ต้องปฏิบัติตามกฎหมายแรงงาน ประกันสังคม หรือกองทุนเงินทดแทน.
• วัน/เวลา/สถานที่ปฏิบัติงาน.
• วันทำงานปกติ: ตามตารางปฏิบัติงาน (อาจมีการเปลี่ยนแปลงตามความเหมาะสม) ทำ 5 วัน หยุด 2 วัน.
• เวลาทำงานปกติ: ทำงานวันละ 8 ชั่วโมง (ไม่รวมเวลาพัก).
• เวลาพัก: 1 ชั่วโมง.
• การลงเวลาทำงาน: พนักงานต้องลงเวลาทำงานทุกครั้งที่เข้างานและเลิกงาน ตามที่ผู้ว่าจ้างกำหนด.
• สถานที่ปฏิบัติงาน: ศูนย์การประชุมแห่งชาติสิริกิต หรือสถานที่ที่ผู้ว่าจ้างกำหนด.
• กรณีที่พนักงานปฏิบัติงานนอกเหนือจากวันและเวลาปกติ สามารถคิดเป็นค่าจ้างเพิ่มเติม โดยอัตราค่าจ้างจะเป็นไปตามที่ผู้ว่าจ้างกำหนด.
• วุฒิการศึกษา ปวส., ปริญญาตรี สาขา IT, Telecom หรือที่เกี่ยวข้อง.
• มีประสบการณ์หรือความรู้เกี่ยวกับด้าน IT & telecom network อย่างน้อย 1 ปี.
• สามารถปฏิบัติงานเป็นกะหรือตามช่วงเวลาที่ผู้ว่าจ้างกำหนดให้ได้.
• สามารถปฏิบัติงำนล่วงเวลาได้ตำมช่วงเวลาที่ที่ผู้ว่าจ้างกำหนดให้ได้.
• สามารถทำงานวันเสาร์ อาทิตย์ และวันหยุดนักขัตฤกษ์.
• สามารถปฏิบัติตามสถานที่ที่ผู้ว่าจ้างกำหนดหรือตามที่ได้รับแจ้งให้ปฏิบัติงาน.
• มี Service mind ที่ดี.
• มีความรู้ความสามารถในการใช้คอมพิวเตอร์ได้เป็นอย่างดี.
• ต้องมีสุขภาพร่างกายแข็งแรง เหมาะสมกับตำแหน่งงานที่รับผิดชอบ ไม่เป็นโรคชนิดหนึ่งชนิดใดต่อไปนี้.
• ต้องมีใบรับรองแพทย์การตรวจร่างกายทั่วไป.
• ไม่เคยได้รับโทษจำคุกโดยคำพิพากษาถึงที่สุดให้จำคุก เว้นแต่เป็นโทษสำหรับความผิดที่ได้กระทำโดยประมาทหรือความผิดลหุโทษ.

ประสบการณ์:

2 ปีขึ้นไป

ทักษะ:

Research, Compliance, Biology, English

ประเภทงาน:

งานประจำ

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased.
• Subjects' right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA manager, CRM, and RCPM.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• WHAT YOU MUST HAVE.
• To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
• Bachelor of Sciences with strong emphasis in science and/or biology would be prefer.
• Minimum 2 Years of clinical research experience which may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC etc.
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Developing skills in Site Management including management of site performance and patient recruitment which monitoring skill and independent professional judgment.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
• Employee Status:
• Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Not Applicable
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R266104.

ทักษะ:

Project Management, Negotiation, English

ประเภทงาน:

งานประจำ

• Developing and leading oncology's pricing, access, and reimbursement strategies through cross functional networking at local and regional levels.
• Supporting the development and execution of integrated value and access strategies relevant to assigned portfolio which align with the wider external affairs strategy and support the achievement of the organization's commercial goals.
• Building and maintaining a deep understanding of the payer landscape, including barriers and opportunities.
• Informing and executing strategic pricing decisions in assigned portfolio, including collaborating with the Head of Market Access, regional market access, and global pricing team on value-based pricing.
• Collaborating with the assigned portfolio BUD to develop market access strategy plans, with a particular emphasis on oncology - key growth drivers and priority products.
• Developing and communicating value propositions for each key stakeholder to achieve market access objectives.
• Developing and communicating evidence submissions to relevant HTA and / or other decision-taking processes.
• Shaping tender design in key therapy areas.
• Designing bespoke approaches to the out-of-pocket market in Thailand, including through business-to-business.
• Identification, analysis, and communication of economic barriers and gaps to access.
• Supervising the development, adaptation, and implementation of Health Economic (HE) models and programs to meet customer needs and achieve commercial targets.
• o Determining outcomes research requirements and developing local data generation strategies in collaboration with a respective TA market access manager.
• o Preparing health technology assessment and dossiers for National listing of essential medicines (NLEM) and tendering submissions.
• o Searching literature and critically reviewing, extracting, and summarizing relevant evidence.
• o Supporting the wider external affairs team to engage in evidence-based conversations with key stakeholders as appropriate.
• o Developing strategy and design, in collaboration with medical affairs, of local data generation studies.
• Real world local data generation (LDG) projects:
• o Designing market access LDG projects in alignment with CORE.
• o Overseeing the data procurement, data analysis, and reporting.
• o Overseeing the publication of findings and dissemination of finding to commercial teams.
• o Present at conferences on the topic of health economics and LDG findings to strengthen value and affordability cases to key leaders in the industry.
• o Develop good relationships with KOLs based on a shared interest in research and scientific methodologies.
• o Provide strategic input into market access and commercial plans.
• o The building of models to explore different scenarios in order to inform strategic decisions. E.g. alternative reimbursement models, business case models for new product launches, pricing strategies, etc.
• o Assist with the analysis of current data and trends, partnering with the relevant market access managers in guiding the commercial teams on strategic decisions.
• o Leadership and strategic counsel.
• Maintaining up-to-date internal knowledge of pricing, listing and tendering systems, including submissions of PARFs for senior leadership and Global approval.
• Developing a thorough understanding of the policy objectives, health priorities, and planned initiatives of government, particularly as they may impact on access for company's oncology franchise.
• Collaborate with Policy colleagues in the assessment of and development of action plan to shape the value frameworks and other policies impacting value assessment.
• Monitoring access and pricing environment.
• WHAT YOU MUST HAVE.
• To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
• University educated to a high level (Bachelor's degree is required; advanced/graduate degree preferred (PhD, MPH, MPP, MBA, other)).
• 5-7 years' experience of the pharmaceutical sector in Thailand.
• Experience of working at a senior level in a market access, marketing or HEOR role.
• Detailed knowledge of the key market access issues relating to oncology or vaccine business, and experience of working to overcome them.
• Evidence of strategic and analytical thought.
• Proven track record of success in developing and implementing access strategies.
• Proven ability to establish strong influential relationships with key stakeholders/government officials.
• Strong organizational and project management skills.
• Demonstrated leadership skills and experience leading and managing cross-functional teams within a matrix organization.
• Demonstrated ability to influence and lead without direct reporting relationships; be a change agent to the cross-functional teams.
• Demonstrated aptitude with commercial & strategic thinking.
• Interpersonal effectiveness, particularly in working productively under pressure with team.
• Fluent English language skills.
• Critical competencies for success.
• Ability to navigate the market access environment: the market access manager will be able to assist in identifying optimal routes to reimbursement, and help develop and address any needs and requirements of the routes identified - including requirements for HTA and/ or tender processes as appropriate.
• Understanding of the payer mindset: the market access manager will have an understanding of, and insights into, the attitudes of payers.
• Other personal characteristics.
• Other desirable personal characteristics include being:
• Highly committed.
• Able to engage a complex set of issues.
• Attentive to detail.
• Of impeccable integrity.
• Calm under pressure.
• Good communication and negotiation skills.
• Able to work in a highly dynamic situation.
• Ability to embrace a mindset of Networking, Empowering, Experimenting, Sharing & Learning, whilst maintaining focus on Purpose, High Integrity &Ethics, Patient-Focus and Diversity & Inclusiveness.
• Our Human Health Division maintains a "patient first, profits later" ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide.
• has context menu.
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
• Employee Status:
• Regular
• Relocation:
• Domestic
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Not Applicable
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R285989.

ประสบการณ์:

3 ปีขึ้นไป

ทักษะ:

Sales, Cloud Computing, Project Management, English

ประเภทงาน:

งานประจำ

• Collaborate with the sales team to increase sales by creating new business opportunities and selling industry-leading new cloud, ICT, and convergence services like cloud infrastructure services, network security, and cloud managed services that generate their own leads, engage in social selling, qualify prospects, and, most importantly, close deals.
• Developing solutions and organizing, planning of IT project.
• Ensuring solutions are best practice and in line with client requirements.
• Managing the cost sheet and Bill of Material (BOM), TOR/RFP.
• Keeping abreast of market trends and product & competitor landscapes.
• Assists customer, prospect, and Sales Representative to build a compelling and competitive business case and ROI (Return of Investment). Manages hand-over to the Services Functions (Post-Sales Support and/or Professional Services) for implementation and post-sales support.
• Build technical and marketing relationship with prospects or existing customers and partners.
• Ability to understand and document complex customer requirements, presenting the technical and commercial propositions, defining the technical and commercial strategy across the DPS portfolio.
• Assists with the qualification of the opportunities and/or identification of target accounts.
• Support with technical qualification of sales opportunities.
• QualificationBackground in Information Technology, Computer Engineering or IT related degree.
• Knowledgeable in IT or Telecom, Networking, Cloud Computing, and Project Management.
• Working experience 3+ years of presales experience.
• Expert area(s) required in System, Network, and Cloud Technology.
• Understand at least one of the following areas:
• Cloud Computing (SaaS/IaaS/PaaS) Cloud Deployment Model Cloud Service Model.
• Cybersecurity.
• Networking and Infrastructure.
• Able to speak, read and write in English Communication.
• Good Negotiation skill, Presentation skill.
• Candidates with prior experience with Microsoft (Azure/M365), AWS, Firewall, Cyber Security, VMware, and HCI will be given preference.
• Key ResponsibilitiesCollaborate with the sales team to increase sales by creating new business opportunities and selling industry-leading new cloud, ICT, and convergence services like cloud infrastructure services, network security, and cloud managed services that generate their own leads, engage in social selling, qualify prospects, and, most importantly, close deals.
• Developing solutions and organizing, planning of IT project.
• Ensuring solutions are best practice and in line with client requirements.
• Managing the cost sheet and Bill of Material (BOM), TOR/RFP.
• Keeping abreast of market trends and product & competitor landscapes.
• Assists customer, prospect, and Sales Representative to build a compelling and competitive business case and ROI (Return of Investment). Manages hand-over to the Services Functions (Post-Sales Support and/or Professional Services) for implementation and post-sales support.
• Build technical and marketing relationship with prospects or existing customers and partners.
• Ability to understand and document complex customer requirements, presenting the technical and commercial propositions, defining the technical and commercial strategy across the DPS portfolio.
• Assists with the qualification of the opportunities and/or identification of target accounts.
• Support with technical qualification of sales opportunities.
• Qualification Background in Information Technology, Computer Engineering or IT related degree.
• Knowledgeable in IT or Telecom, Networking, Cloud Computing, and Project Management.
• Working experience 3+ years of presales experience.
• Expert area(s) required in System, Network, and Cloud Technology.
• Understand at least one of the following areas:
• Cloud Computing (SaaS/IaaS/PaaS) Cloud Deployment Model Cloud Service Model.
• Cybersecurity.
• Networking and Infrastructure.
• Able to speak, read and write in English Communication.
• Good Negotiation skill, Presentation skill.
• Candidates with prior experience with Microsoft (Azure/M365), AWS, Firewall, Cyber Security, VMware, and HCI will be given preference.
• Recruiter Alisa Promchotchai (อลิสา พรหมโชติชัย)

ประสบการณ์:

1 ปีขึ้นไป

ทักษะ:

Compliance, Biology, Research, English

ประเภทงาน:

งานประจำ

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure the data generated at site are complete, accurate and unbiased which Subjects' right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM and CCQM.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• WHAT YOU MUST HAVE.
• To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
• Bachelor of Sciences with strong emphasis in science and/or biology would be prefer.
• Minimum 1 Years of clinical research experience which may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC etc.
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Developing skills in Site Management including management of site performance and patient recruitment which monitoring skill and independent professional judgment.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
• Employee Status:
• Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Not Applicable
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R266105.

ประสบการณ์:

5 ปีขึ้นไป

ทักษะ:

Research, Compliance, Biology, English

ประเภทงาน:

งานประจำ

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
• Data generated at site are complete, accurate and unbiased.
• Subjects' right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA manager, CRM and if applicable, RCPM.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
• Could perform Quality control visits if delegated by other roles and trained appropriately.
• WHAT YOU MUST HAVE.
• To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows:
• Bachelor of Sciences with strong emphasis in science and/or biology would be preferred.
• Minimum 4-5 Years of clinical research experience which may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC etc.
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Developing skills in Site Management including management of site performance and patient recruitment which monitoring skill and independent professional judgment.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus.
• We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• Search Firm Representatives Please Read Carefully
• Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
• Employee Status:
• Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Remote
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R257594.