ประเภทงาน:

งานประจำ

• Valuation and Targeting: ensure effective targeting of high value customers.
• Sales Planning: achieve sales, activity and field promotion objectives..
• Promotion Cycle Management: ensure effective execution in alignment with the promotional strategy at territory level.
• Formulary Listing: ensure formulary listing success of company products.
• Customer Focused Selling: shape customer behaviors.
• Territory Management: maximize effectiveness and efficiency of call activities..
• Other Customer Contacts: capitalize on other customer contacts effectively to influence physicians' perception and prescribing behavior.
• Field Visit Management: develop skills required for customer focused selling.
• Tracking and Responding To Results: achieve territory objectives and respond promptly to changes in the market.
• Talent Management: enhance personal skill development to deliver strategic and operational performance.
• 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's in Veterinary Science, Veterinary Medicine or related field.
• Preferable at least 2 years' experience of Sales in Pharmaceutical, ethical channel.
• Be able to travel, country work, after hours and occasional weekend work.
• Emphasis on Customer Focus and Sales Planning.
• Understanding of pharmaceutical industry and local competitor information.
• Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.
• Through our commitment to The Science of Healthier Animals , we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.
• 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:
• No
• Travel Requirements:
• Flexible Work Arrangements:
• Hybrid
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R284009.

ทักษะ:

Assurance, Compliance, GMP

ประเภทงาน:

งานประจำ

• Local batch release includes coordination of Vaccine release by the Health Authority.
• Ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good Distribution Practice) are fulfilled (where applicable as per the country distribution model).
• Where applicable, ensure adherence to AP regional QMS and provide feedback to AP In-market Quality topic owners.
• Ensure Quality perspective is brought into local business initiatives with Quality impact.
• Support local coordination and execution of recalls.
• Support commutation with our Manufacturing Division Quality.
• Support communication with HA issues pertaining to Quality and Supply issues.
• Reports to the In-market Quality lead for Thailand for general advice and instruction concerning Quality Operations.
• Receives guidance, management, and direction and when necessary; executes responsibilities under manager's oversight.
• Keeps manager informed on the status of operations and when challenges, opportunities and/or issues arise.
• Must be Locally registered pharmacist with a valid registered pharmacist license.
• Must have expertise and experience in Quality area (GMP and/or GDP), and nice to have in Supply Chain or Regulatory Affairs.
• Must have the ability to influence management of complex operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
• Must have interpersonal and communication skills in dealing with complex matter.
• Must have exemplary people/team collaboration experience, including speaking candidly, and motivating teams.
• 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:
• No relocation
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Hybrid
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R286203.

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.

ทักษะ:

Finance, Budgeting, Research, English

ประเภทงาน:

งานประจำ

• Trial and site administration:
• o Clinical supply & non-clinical supply management (mainly focus on import and export), in collaboration with other country roles.
• o Update clinical trial databases, report and trackers as required
• o Ensure collation and distribution of study tools aFnd documents.
• Document management:
• o Prepare documents and correspondence
• o Collate, distribute/ship, and archive clinical documents
• o Assist with eTMF reconciliation and execute eTMF Quality Control Plan
• o Document proper destruction of clinical supplies.
• o Prepare Investigator trial file bindersAgreement and Payments: Collaborate with finance/budgeting representatives for:
• o Ensure adherence to financial and compliance procedures
• o Monitor and track adherence and disclosures
• o Maintain tracking tools
• o Obtain and process FCPA documentation in a timely manner Skills:Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Hands on knowledge of Good Documentation Practices.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
• ICH-GCP Knowledge appropriate to role.
• Excellent negotiation skills for CTCs in finance area.
• Effective time management, organizational and interpersonal skills, conflict management.
• Effective communication with external customers (e.g. sites and investigators).
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus, both internally and externally.
• Able to work independently.
• Proactive attitude to solving problems / proposing solutions.
• Positive mindset, growth mindset.
• Qualification & Experience:Bachelor's Degree.
• Experience in logistics will be advantage, but not a must.
• 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:
• Hybrid
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R286274.

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.

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:

2 ปีขึ้นไป

ทักษะ:

Compliance, Finance, Legal, English

ประเภทงาน:

งานประจำ

• Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations.
• Interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Coordinates and liaises with CRM, CTC, CRA, other functions areas to ensure country.
• deliverables are obtained for submissions, budgets, CTRAs and local milestones.Support of local regulatory and financial compliance. Ability to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related- interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
• Coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical systems.
• Provide support and oversight to local vendors as applicable.
• Contributes to the development of local SOPs.
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
• Contributes strongly to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Contributes to COM team knowledge by sharing best practices appropriate/required.
• May act as buddy / mentor.
• Skills:Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.
• Knowledge of core clinical systems, tools and metrics.
• Excellent verbal and written skills, in local language and English.
• Strong coordination and organizational skills.
• Knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager.
• Ability to make decisions independently with oversight from Line Manager.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. ICH/GCP knowledge appropriate to role. Good knowledge of Good Documentation Practices.
• Able to work with other experienced clinical research professionals and manage select protocols independently. Works with high quality and compliance mindset.
• Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, contribute to root cause analysis, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
• Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
• High sense of accountability and urgency in order to properly prioritize deliverables.
• Strong communication and negotiation skills as well as developing skills in influencing and training/mentoring, both written and verbal, in local language and English.
• Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Able to directly influence site staff.
• Qualification & Experience:2-5 years of experience in Clinical Research.
• Preferred: Bachelor's degree.
• 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:
• Hybrid
• Shift:
• Valid Driving License:
• Hazardous Material(s):
• Requisition ID:R285995.

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.