Filter Jobs

Skills:

Risk Management, Compliance

Job type:

Full-time

• Invite and give in the moment feedback in a constructive manner.
• Share and collaborate effectively with others.
• Identify and make suggestions for improvements when problems and/or opportunities arise.
• Handle, manipulate and analyse data and information responsibly.
• Follow risk management and compliance procedures.
• Keep up-to-date with developments in area of specialism.
• Communicate confidently in a clear, concise and articulate manner - verbally and in the materials I produce.
• Build and maintain an internal and external network.
• Seek opportunities to learn about how PwC works as a global network of firms.
• Uphold the firm's code of ethics and business conduct.
• Education (if blank, degree and/or field of study not specified).
• Degrees/Field of Study required: Degrees/Field of Study preferred:Certifications (if blank, certifications not specified).
• Required Skills.
• Optional Skills.
• Desired Languages (If blank, desired languages not specified).
• Travel Requirements.
• Not Specified
• Available for Work Visa Sponsorship?.
• No
• Government Clearance Required?.
• No
• Job Posting End Date.

Job type:

Full-time

• 2) Propose and suggest business improvement and practical recommendation to address risks or weakness for the organisation
• 3) Manage audit works to ensure completion within timeline
• 4) Follow up the actions to ensure the correctively improvement in the audit report
• 5) Coordinate with Group Risk Management and Group Internal Audit

Experience:

8 years required

Skills:

Accounting, Internal Audit, CPA, English

Job type:

Full-time

• Development and implementation of the overall internal audit strategies, standards, policies, regional initiatives.
• Development and implementation internal audit tools, electronics working paper, audit tracking system to assist internal audit work and enhancing audit methodology with best practices.
• Conduct periodic quality assurance reviews to ensure conformance with best practices and adherence to established internal audit policies and procedures.
• Track Internal Audit s performance and activities, and relevant Management Information System reports to Head of Corporate Assurance, Audit Committee and Management.
• Prepare MIS reports/presentation materials for Audit Committee/Management meetings of CIMB Thai and Group including take minutes and follow up on matters arising.
• Bachelor's Degree in Accounting, Financial or related fields.
• Holding CPA or CIA are preferable.
• Minimum 5 years experienced in Accounting, Auditing and/or Management in Bank or Financial Institutions.
• Knowledge if the financial services business and its operations, including the rules and regulations in the domestic and international landscape (as applicable).
• Proficient in auditing guidelines, regulatory requirements, directives and guidelines issued by the relevant authorities and associations of the banking industry.
• Good Communications and Presentation skill in English.
• Good analytical & MIS skill.
• For the further discussion please contact: Nitchakarn (061-2500920).

Skills:

Data Analysis, Big Data, Oracle, English

Job type:

Full-time

• Perform an IT audit and testing ITGC (Information Technology General Computer Control), Data Analysis and utilize technology effectively.
• Take part of integrated audit by performing test of IT dependency controls e.g., automated application control, IT dependent report, system access and authorization control.
• Analyze and solve problems especially big data analysis.
• Assess and giving advice on IT/network security architecture design.
• Assess risk related to information and cybersecurity and evaluate effectiveness of internal controls based on industrial-accepted standard e.g., Information Security Management System (ISMS).
• Assess and giving advice on security technology and security-related configuration e.g., firewall, IDS/IPS, Content filtering, Network routing equipment, Wifi controller, Network access Control, etc.
• Provide overall co-ordination of the audit planning for the areas/ programs under his/her supervision, and supervise the follow up process of subordinates to ensure timely dispatch of audit reports to auditee and obtaining reply from auditee on the implementation status of recommendations.
• Delegate, allocate and assign resources to carry out the audit work, and advise, supervise, and oversee the audit activities carried out by the IA as per the Annual Audit Plan.
• Discuss with GCAE for major risk or audit findings identified during audit.
• Oversee the follow up process of the Senior Internal Auditor to ensure timely dispatch of audit reports to auditee and obtaining reply from auditee on the implementation status of recommendations.
• Review and discuss on the reply received from auditee for any disputes or disagreement.
• To ensure that audit engagements are conducted in accordance with the audit work program and objectives of the audit have been achieved.
• Carry out special / investigation audit assigned by GCAE.
• Participate in the Exit meeting with auditee s management to discuss on the audit findings identified during audit.
• Bachelor's degree preferably in IT, Computer Science or Engineering, Statistic.
• Having 3-5 years of experience in Professional IT Auditor or an equivalent function or experience in auditing firms or as internal auditor more than 7 years.
• Preferably proficient in Oracle or any other related Accounting System. Working knowledge in IT Auditor; highly proficient with ERP configurations e.g., SAP and Oracle. Ability to apply best practices of one ERP system in other ERP systems.
• Able to work to upcountry or overseas.
• Preferably a CISA.
• Excellent communication skills in both oral and written English.
• Able to appreciate business process issues and understand business transaction scenarios, and how an application system (e.g., SAP, Oracle, etc.) can support them.
• Basic understanding of ERP configurations e.g., SAP, Oracle. Ability to apply best practices of one ERP system in other ERP systems.
• Resourceful and able to work out technical solutions.
• Good appreciation of fundamental accounting knowledge and/or audit knowledge and financial controls.
• Good grasp of IT technical concepts, e.g., Operating Systems (Unix, Windows, etc), Databases (Oracle, SQL, etc.).
• Able to handle multiple tasks and assignments.
• Logical thinking, good attitude, fast learner and good team player.
• Working independently without closely supervisor.
• Ability to persuade and influence others, to motivate others and promote teamwork and mentor any others, and to provide effective feedback.
• Certification/Licensure Certified Information System Auditor (CISA), (Preferred).
• Lotus's
• Ek-Chai Distribution System Co., Ltd.
• Buengkum, Bangkok 10230, Thailand.
• By applying for this position, you consent to the collection, use and disclosure of your personal data to us, our recruitment firms and all relevant third parties for the purpose of processing your application for this job position (or any other suitable positions within Lotus's and its subsidiaries, if any). You understand and acknowledge that your personal data will be processed in accordance with the law and our policy. .

Skills:

Risk Management, Compliance, Creativity

Job type:

Full-time

• Perform targeted fieldwork to review and conduct audit of general IT control such as: IT Risk Management, Access Control, Asset Management, Physical and Environmental, Business Continuity Management, IT Service Management, IT Operation, Vulnerability and Patch Management, Protection from malware, IT Communication, Application and Database Control, as well as key business processes. -Prepare audit report, presentation and get respond from auditee.
• Assist in review and update IT Audit Universe, BU/BP business flow and process.
• Prepare audit program, review risk related with IT control in both technical & compliance area.
• Follow-up with BU/BP for progress of control implement as per audit recommendation.
• Perform other special projects and assignment.
• Bachelor s or master degree in IT and related field.
• 1-2 years experience in IT General and Application controls audit.
• Knowledge in IT Audit, IT Security, IT Risk or IT Compliance.
• Creativity, adaptability, analytical, problem solving and project management skills with agility mindset.
• Understand Business process, IT process, operation, data structure and data flow in application and intra application.
• Understand business impact and risk assessment.
• Technical document writing, manual and report writing.

Skills:

Excel, Power point, Visio

Job type:

Full-time

• Assist Manager to control cost and expense according to audit plan.
• Perform audit work of internal auditor according to standard within timeline.
• Collect, analyze and review information following audit program.
• Discuss about audit observation and share ideas with all concerned.
• Assist Manager /Senior Manager to report progress of audit work and significant urgent case during audit work i.e. fraud or damage of Company s assets.
• Assist Manger/Senior Manager to monitor to have follow-up process and assess conformance to Group Internal Audit Division s recommendation.
• Perform other special projects and duties as assigned.
• Qualifications:Bachelor s or Master s degree in accounting or related field.
• Have at least 8 years of experience in Internal Audit Function.
• Written and verbal communications skills.
• Computer literacy (i.e. Excel, Power Point, Word, Visio, etc.).
• Analytical and systematic thinking skill.
• Berli Jucker Public Co.,Ltd.
• Human Resources Division
• 99 Soi Rubia, Sukhumvit 42, Phrakanong, Klongtoey, Bangkok 10110.

Job type:

Full-time

• ระดับตำแหน่งงาน: ระดับพนักงาน.
• ประเภทการจ้างงาน: -.
• บริษัท: บริษัท เบอร์ลี่ ยุคเกอร์ จำกัด (มหาชน).
• สถานที่ทำงาน: สุขุมวิท 42.
• Perform targeted fieldwork to review and conduct audit of general IT control such as: o IT Risk Management, Access Control, Asset Management, Physical and Environmental, Business Continuity Management, IT Service Management, IT Operation, Vulnerability and Patch Management, Protection from malware, IT Communication, Application and Database Control, as well as key business processes. Prepare audit report, presentation and get respond from auditee.
• Assist in review and update IT Audit Universe, BU/BP business flow and process.
• Prepare audit program, review risk related with IT control in both technical & compliance area.
• Follow-up with BU/BP for progress of control implement as per audit recommendation.
• Perform other special projects and assignment.
• Bachelor s or master degree in IT and related field.
• 1-2 years experience in IT General and Application controls audit.
• Knowledge in IT Audit, IT Security, IT Risk or IT Compliance.
• Creativity, adaptability, analytical, problem solving and project management skills with agility mindset.
• Understand Business process, IT process, operation, data structure and data flow in application and intra application.
• Understand business impact and risk assessment.
• Technical document writing, manual and report writing.
• สมัครงาน.

Skills:

Risk Management, Compliance

Job type:

Full-time

• Invite and give in the moment feedback in a constructive manner.
• Share and collaborate effectively with others.
• Identify and make suggestions for improvements when problems and/or opportunities arise.
• Handle, manipulate and analyse data and information responsibly.
• Follow risk management and compliance procedures.
• Keep up-to-date with developments in area of specialism.
• Communicate confidently in a clear, concise and articulate manner - verbally and in the materials I produce.
• Build and maintain an internal and external network.
• Seek opportunities to learn about how PwC works as a global network of firms.
• Uphold the firm's code of ethics and business conduct.
• Education (if blank, degree and/or field of study not specified).
• Degrees/Field of Study required: Degrees/Field of Study preferred:Certifications (if blank, certifications not specified).
• Required Skills.
• Optional Skills.
• Desired Languages (If blank, desired languages not specified).
• Travel Requirements.
• Not Specified
• Available for Work Visa Sponsorship?.
• No
• Government Clearance Required?.
• No
• Job Posting End Date.

Experience:

3 years required

Job type:

Full-time

• Plans, develops & completes functional, compliance & other audit activities within specified time periods.
• Creates & maintains audit files and documents work performed to department standards.
• Evaluates audit results to determine the quality and effectiveness of internal operating policies, internal controls, regulatory requirements, administrative procedures & reporting practices.
• Identifies gaps in internal controls and provide recommendations for improvements where necessary.
• Uses IA databases to aid in the writing of the reports.
• Reports audit findings and recommendations to management.
• Drafts formal, clearly written and complete audit reports summarizing findings, conclusions and recommendations & works with stakeholders to obtain written responses to each of the comments.
• Communicate audit findings, recommend new policies and procedures as needed.
• Performs other duties and special projects as assigned.
• Bachelor s Degree or Master's Degree in Business Administration.
• 3-5 years of internal audit experience with public company.
• Ability to work & travel independently, is a self-starter and move projects forward by meeting project deadlines, manages multiple projects and assignments.
• Strong verbal and written communication and presentation skills.

Skills:

Compliance

Job type:

Full-time

• Proactively assist the team in various aspects of the project.
• Prepare deliverables.
• Contribute to the development of your own and team's technical acumen.
• Keep up to date with local and national business and economic issues.
• Ensure you are adhering to compliance matters.
• Work on developing internal relationships and your PwC brand.
• Education (if blank, degree and/or field of study not specified).
• Degrees/Field of Study required: Degrees/Field of Study preferred:Certifications (if blank, certifications not specified).
• Required Skills.
• Optional Skills.
• Desired Languages (If blank, desired languages not specified).
• Travel Requirements.
• Not Specified
• Available for Work Visa Sponsorship?.
• No
• Government Clearance Required?.
• No
• Job Posting End Date.

Skills:

Risk Management, Compliance

Job type:

Full-time

• Invite and give in the moment feedback in a constructive manner.
• Share and collaborate effectively with others.
• Identify and make suggestions for improvements when problems and/or opportunities arise.
• Handle, manipulate and analyse data and information responsibly.
• Follow risk management and compliance procedures.
• Keep up-to-date with developments in area of specialism.
• Communicate confidently in a clear, concise and articulate manner - verbally and in the materials I produce.
• Build and maintain an internal and external network.
• Seek opportunities to learn about how PwC works as a global network of firms.
• Uphold the firm's code of ethics and business conduct.
• Education (if blank, degree and/or field of study not specified).
• Degrees/Field of Study required: Degrees/Field of Study preferred:Certifications (if blank, certifications not specified).
• Required Skills.
• Optional Skills.
• Desired Languages (If blank, desired languages not specified).
• Travel Requirements.
• Not Specified
• Available for Work Visa Sponsorship?.
• No
• Government Clearance Required?.
• No
• Job Posting End Date.

Skills:

Risk Management, Compliance

Job type:

Full-time

• Invite and give in the moment feedback in a constructive manner.
• Share and collaborate effectively with others.
• Identify and make suggestions for improvements when problems and/or opportunities arise.
• Handle, manipulate and analyse data and information responsibly.
• Follow risk management and compliance procedures.
• Keep up-to-date with developments in area of specialism.
• Communicate confidently in a clear, concise and articulate manner - verbally and in the materials I produce.
• Build and maintain an internal and external network.
• Seek opportunities to learn about how PwC works as a global network of firms.
• Uphold the firm's code of ethics and business conduct.
• Education (if blank, degree and/or field of study not specified).
• Degrees/Field of Study required: Degrees/Field of Study preferred:Certifications (if blank, certifications not specified).
• Required Skills.
• Optional Skills.
• Desired Languages (If blank, desired languages not specified).
• Travel Requirements.
• Available for Work Visa Sponsorship?.
• Government Clearance Required?.
• Job Posting End Date.

Experience:

6 years required

Skills:

Assurance, Accounting, CPA, English, Thai

Job type:

Full-time

• Assist in carrying out quality audit and other assurance services to clients in multiple services.
• Identify and communicate accounting and auditing matters to partners.
• Identify performance improvement opportunities.
• Interact with clients to help ensure that the information flow from the client to the audit team is efficient.
• Help prepare audit budgets, plans, proposals and presentations.
• Provide coaching and feedback to junior team members.
• Bachelor's Degree or above in Accounting.
• 6+ years of external audit experience.
• CPA qualification.
• Team player with strong interpersonal, communication and project management skills.
• Proficiency in spoken and written English & Thai.
• Education (if blank, degree and/or field of study not specified).
• Degrees/Field of Study required: Degrees/Field of Study preferred: Bachelor DegreeCertifications (if blank, certifications not specified).
• Required Skills.
• Optional Skills.
• Desired Languages (If blank, desired languages not specified).
• Travel Requirements.
• Up to 80%
• Available for Work Visa Sponsorship?.
• No
• Government Clearance Required?.
• No
• Job Posting End Date.

Job type:

Full-time

Job Description จัดทำ ประเมิน และติดตามแผนงานประจำปี ด้วยการประเมินและระบุความเสี่ยงที่สำคัญในองค์กร (Potential Risk Identification) ที่อาจส่งผลกระทบทางธุรกิจ เพื่อทำการวางแผนงานตรวจสอบประจำปี และปรับปรุงแผนงานระหว่างปี พร้อมนำเสนอให้แก่คณะกรรมการตรวจสอบและกำกับความเสี่ยงของบริษัท กำกับดูแลและบริหารงานตรวจสอบด้าน Data Governance ด้านเทคโนโลยีสารสนเทศ และด้านต่างๆที่ส่งผลกระทบต่อการดำเนินธุรกิจของบริษัท โดยมีการสอบทาน การระบุความเสี่ยง การตรวจสอบ และการนำเสนอข้อปรับปรุงให้แก่ฝ่ายจัดการของผู้ตรวจสอบ (Audit Project Manager) ให้มีความเหมาะสม มีมาตรฐาน และทันเวลา อีกทั้ง มีการนำเสนอรายง ...

Job type:

Full-time

• Job Posting Location Nakhon Ratchasima
• Job Summary acquire new registration post-paid and sales other company's product
• Job Description acquire new registration post-paid and sales other company's product Recruiter Artitaya Wongkrawthanawat (อาทิตยา วงแก้วธนวัต), Primrata Jaisin (พริมระตา ใจศิล), Siraprapa Chaisaokomut (ศิรประภา ชัยเสาโกมุท)

Skills:

Accounting, Coordinate, Quality Assurance, Thai, English

Job type:

Full-time

• Citi provides programs and services for your physical and mental well-being including access to telehealth options, health advocates, confidential counseling and more. Coverage varies by country.
• We believe all parents deserve time to adjust to parenthood and bond with the newest members of their families. That's why in early 2020 we began rolling out our expanded Paid Parental Leave Policy to include Citi employees around the world.
• We empower our employees to manage their financial well-being and help them plan for ...
• Citi provides access to an array of learning and development resources to help broaden and deepen your skills and knowledge as your career progresses.
• We have a variety of programs that help employees balance their work and life, including generous paid time off packages.
• We offer our employees resources and tools to volunteer in the communities in which they live and work. In 2019, Citi employee volunteers contributed more than 1 million volunteer hours around the world.
• In this role, you're expected to:
• Accurately spreads business financial statements and business and individual tax returns on a timely basis and in accordance with Generally Accepted Accounting Principles (GAAP) and Citibank policies and ensure that financial data for simple to complex credits are mapped appropriately into the bank's matrix and analysis tool.
• Provide comments to the Underwriter on significant items in the financials and may be involved in credit structure and loan pricing. Additional responsibilities may include being a specialist for a designated industry and the effective interaction with Credit Officers and Relationship Managers while providing assistance regarding the analysis of the applications.
• Spread new, renewal and interim financial statements and business and individual tax returns in accordance with bank guidelines (focus on more complex financial statements).
• Provide preliminary analysis of simple to complex credits, including calculation of cash flow, debt service coverage, projections, collateral coverage, and guarantor net worth. Prioritize and perform timely credit evaluation, both quantitative and qualitative, of credit applications/ requests and annual or periodic credit reviews within established turnaround benchmarks.
• Provide preliminary analysis of simple to complex credits, including calculation of cash flow, debt service coverage, projections, collateral coverage, and guarantor net worth.
• Prioritize and perform timely credit evaluation, both quantitative and qualitative, of credit applications/ requests and annual or periodic credit reviews within established turnaround benchmarks.
• Coordinate with the Risk Team, Credit Analysts, Other Credit Center Staff and Relationship Managers and act in an advisory role for the Credit Officers/Relationship Managers on loan agreement/covenants clarification and monitoring.
• Complete quality assurance reviews to ensure application packages and analysis are thorough and accurate prior to forwarding for underwriting.
• Maintain an in-depth knowledge of Citi policies, programs, procedures and applicable local and US regulations to assist the Business in achieving compliance and satisfactory internal and external audit results.
• Contribute/ generate ideas and participate in periodic projects for improving lending process efficiency or other related initiatives.
• Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency.
• As a successful candidate, you'd ideally have the following skills and exposure:
• 5 -10 years prior experience in a financial institution with a focus on credit analysis and spreading software.
• Extensive knowledge of accounting, financial regulations, financial products, and credit analysis.
• Strong analytical skills and credit writing ability, including ability to perform financial/ cash flow projections.
• Good knowledge and familiarity of local market, banking products and applicable local regulations.
• Able to work independently as well as in a team with strong initiative and high level of integrity.
• Ability to handle high volume, prioritize and work under pressure to meet tight deadlines.
• Fluent in Thai and English.
• Job Family Group:
• Risk Management Job Family:
• Business Risk & Control Time Type:
• Full time Citi is an equal opportunity and affirmative action employer.
• Qualified applicants will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• Citigroup Inc. and its subsidiaries ("Citi") invite all qualified interested applicants to apply for career opportunities. If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity review Accessibility at Citi.
• View the "EEO is the Law" poster. View the EEO is the Law Supplement.
• View the EEO Policy Statement.
• View the Pay Transparency Posting.

Experience:

2 years required

Skills:

Research, Compliance, Biology, English

Job type:

Full-time

• 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.

Experience:

5 years required

Skills:

Research, Compliance, Biology, English

Job type:

Full-time

• 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.