Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description: At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Import/Export Coordinator – Licensed/Registered Pharmacist Summarized Purpose: Responsible and accountable for the planning and execution of moderate to complex Import & Export activities for assigned studies in Thailand, including coordination of import licence and regulatory requirements. The role also supports applicable Thai FDA clinical-trial regulatory activities requiring a qualified pharmacist and acts as a subject matter resource for regulatory requirements related to the importation of investigational medicinal products. The position coordinates Import & Export transactions through delivery to depots/sites, supports import licence submissions and maintenance, maintains required documentation and metrics, and works closely with Clinical Operations, Regulatory Affairs, Quality, Project Delivery, sponsors, vendors and other stakeholders to ensure compliant and timely clinical trial execution. Essential Functions and Other Job Information: - Plan and execute Import & Export activities for assigned clinical studies in accordance with PPD, client, and applicable regulatory requirements. - Ensure an appropriate Import & Export plan is established and maintained for assigned projects. - Review, collect, prepare, and maintain documentation required for Import Licences, permits, customs clearance, and shipment activities. - Support PPD Thailand's Importer of Record (IoR) operations, including application, maintenance, and compliance requirements associated with the Thai FDA Drug Importer Licence. - Fulfil applicable responsible pharmacist responsibilities associated with PPD Thailand's Drug Importer Licence in accordance with Thai FDA requirements. - Prepare, review, and coordinate applicable Thai FDA clinical trial applications and regulatory submissions, including relevant amendments, notifications, and responses to Thai FDA queries. - Support applicable clinical trial regulatory activities throughout the study lifecycle, including assessment of regulatory requirements, maintenance of approvals/documentation, and study close-out activities within the scope of the role. - Monitor Thai FDA, Import/Export, and relevant clinical trial regulatory requirements and communicate changes, requirements, or compliance risks to relevant stakeholders. - Coordinate with Clinical Operations, Regulatory Affairs, Quality, Project Delivery, sponsors, Customs Brokers, Couriers, Depots, and other stakeholders to support timely and compliant clinical trial execution. - Maintain accurate, traceable, and inspection-ready Import/Export, IoR, Drug Importer Licence, and clinical trial regulatory documentation and support applicable audits or Thai FDA inspections. - Maintain applicable operational metrics, trackers, and reports, and support process improvements, SOPs/work instructions, and appropriate escalation of operational or compliance issues. - Perform other Import/Export, logistics, regulatory-support, and administrative activities according to business and departmental needs. Job Complexity Works on assignments that range from semi-routine to moderately complex in nature and recognizes the need for deviation from established practices where required. Applies Import/Export, clinical supply and applicable regulatory knowledge to identify issues and support compliant solutions. Job Knowledge Applies acquired Import/Export, clinical supply, pharmaceutical and regulatory knowledge together with company policies and procedures to complete assigned responsibilities. Supervision Received Normally follows established procedures for routine work and requires guidance for new or complex assignments. Expected to independently manage assigned Import/Export and applicable regulatory activities and escalate issues appropriately. Business Relationships Contacts are typically with individuals within the Import/Export organization and regularly with Clinical Operations, Regulatory Affairs, Quality, Project Delivery, sponsors, Customs Brokers, Forwarders, Couriers, Depots and Thai regulatory authorities. Contacts involve obtaining, providing and interpreting information requiring professional judgment and explanation. Qualifications (Preferred/Advantageous unless noted otherwise): - Bachelor’s degree or higher in Pharmacy / Pharmaceutical Sciences from a recognized university. - Valid professional pharmacist licence/registration in Thailand, as required for the responsible pharmacist role. - Knowledge of Thai FDA requirements applicable to clinical-trial importation and investigational medicinal products. - Knowledge of Import/Export requirements and clinical supply chain processes. - Working knowledge of Good Clinical Practice and relevant clinical research requirements. - Experience with Thai FDA applications, import licences or related regulatory submissions is advantageous. - Experience in a pharmaceutical company, CRO, clinical research or other regulated healthcare environment is advantageous. - Proficiency in Microsoft Excel, Word and other standard business applications. - Good English communication skills, both written and verbal. - Thai language proficiency required for local regulatory and stakeholder interactions. - Strong organizational, documentation and timeline-management skills. - Strong stakeholder management and problem-solving skills. Knowledge, Skills and Abilities: - Good awareness of the Clinical Supply Chain process, including Imports, Shipping, Delivery and Exports. - Knowledge of local Import/Export and pharmaceutical regulatory requirements. - Ability to review and maintain regulatory and Import/Export documentation in an inspection-ready manner. - Ability to interact effectively with Thai FDA/regulatory authorities and internal/external stakeholders. - Daily interaction with Customs Brokers, Forwarders, Couriers and Depots. - Ability to identify compliance risks and recommend appropriate solutions. - Strong attention to detail and ability to manage multiple priorities and timelines. - Strong written and verbal communication skills. - Customer-focused approach aligned with high standards of quality and excellence. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job-related skills − Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation, influencing and site engagement skills. − Is a self-starter and able to work within remote teams and independently. − Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity. − Good interpersonal skills, including managing difficult conversations with Investigator & site staff, ability to discuss site trends. − Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic environment. − Respects confidentiality in terms of Personal Information (PI)/ Personal Health Information − Proactive, conscientious, and precise in delivery of quality work even when under pressure − Effective at analysing and escalating issues at the right functional level, solving problems using critical thinking and performing root cause analysis and resolving conflicts in a timely manner. − Flexible with high learning and change agility. − Proficient in Risk Based Quality Management, comfortable utilizing GSK’s RBQM systems/tools to inform on site risk and guide monitoring visit, process-based site management. − Collaborative, building strong internal and external relationships. − Knowledge of local regulations, IND/ICH GCP - guidelines, − Available and willing to travel as job requires and the ability and willingness to learn and master new or evolving computer systems to support business requirements effectively. − Strong computer skills with good eye for detail. Job responsibilities − Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team in a timely manner. − Engage and maintain good written and verbal communication with external and internal stakeholders in order to ensure effective study execution. − Accountable for local activities required in site set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate: − Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out visits. − Performs site evaluation visits. − Determines the feasibility of the study protocol with reference to study complexity. − Confirms staff availability, suitable clinical facilities, potential for per protocol patient population, − Confirms Investigator and site staff have robust processes for conducting the current protocol (GSK standard and study-specific) − Confirms ability to comply with ICH GCP and GSK requirements for clinical studies. − Works with GSK Study staff to carry out a local study level risk assessment, accountable for site risk assessment. − Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face GSK trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical study. − Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigator’s participation in global meetings and/or may assist the GSK study staff with organizing local investigator meetings. Participates in other study meetings as required. − Maintain good relationship with Investigator and site staff and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met. − Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP) including Investigator oversight and appropriate delegation. − Lead and encourage site accountability for ongoing, robust subject recruitment & retention discussions with Investigator and site staff, including recruitment planning, barriers to recruitment, potential mitigations. − Conducts monitoring visits in accordance with Trial Monitoring Plan; monitors to confirm adherence to described site process (GSK standard & study-specific); prepare in advance of monitoring visit by utilizing GSK’s RBQM system/tools to inform on site risk and guide monitoring visit. − Able to successfully conduct remote/off-site monitoring visits using all tools available for remote/offsite tasks. − Work with sites to ensure timely data entry and data query resolution. − Ensure source documents adhere to ALCOAC+ standards, ensure filing and review of source documentation in the appropriate location in the eTMF in a timely manner and ensure adherence to site stated processes (GSK standard & study specific) − Ensure Investigator and site staff receives safety reports and reviews new safety information in a timely manner. − Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to GSK safety department and other relevant departments, within the required time frames. − Completes high quality monitoring visit reports within the agreed timelines, ensuring the report reflects the conduct of the visit; escalating important issues promptly via phone/email − Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e., EDC, CTMS, IRT). − Investigate trends/findings from GSK Central Monitoring group with Investigator and site staff, determining root cause and actions needed and provide information back to Central Monitoring, as requested. − Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately. − Ensure site is meeting quality requirements and is inspection ready at all times. − Ensure sponsor study records are inspection ready at all times and archives records to ensure compliance with GSK TMF submission timelines. − Knowledge of local regulatory environment e.g. If working in Europe, knowledge of EUCTR process and documentation required − Review of KRI data within the GSK RBQM systems to inform on site risk and guide monitoring visit, process-based site management adequately.
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The CRA Level I performs and coordinates different aspects of the clinical monitoring and site management process. The role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. The CRA manages procedures and guidelines across different sponsors and/or monitoring environments, including FSO, FSP, and Government environments. The CRA acts as a site processes specialist, ensuring clinical trials are conducted according to the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, with the objective of protecting subjects' rights and well-being and ensuring data reliability and audit readiness. The role also develops collaborative relationships with investigational sites. Key Responsibilities Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving to identify process failures and implement corrective/preventive actions. Ensure data accuracy through SDR, SDV, and CRF review, as applicable, through on-site and remote monitoring. Assess investigational product through physical inventory and records review. Document monitoring observations in reports and letters and promptly escalate deficiencies or issues to clinical management, following them through resolution. Maintain contact with investigational sites between monitoring visits to confirm protocol adherence, resolution of previously identified issues, and timely data recording. Conduct monitoring activities according to the approved monitoring plan. Participate in investigator payment processes and collaborate with project team members on issue/finding resolution. Participate in investigator meetings and potentially assist with identifying qualified investigators/sites. Initiate clinical trial sites according to applicable procedures and ensure compliance with protocol, regulatory, and ICH-GCP obligations. Perform trial close-out activities and retrieval of trial materials. Ensure required essential documents are complete and available according to ICH-GCP and applicable regulations, including conducting on-site file reviews. Provide trial status tracking and progress reports. Ensure study systems, including Clinical Trial Management Systems (CTMS), are complete, accurate, and up to date. Facilitate effective communication among investigative sites, clients, and internal project teams. Respond to company, client, and applicable regulatory requirements, audits, and inspections. Complete administrative tasks such as expense reports and timesheets. Assist the project team in preparing project publications/tools and contribute ideas and suggestions. Participate in project work and process-improvement initiatives. Travel extensively; the document specifies a travel requirement higher than 75%, while the working-conditions section describes travel as generally 60–80%, potentially more for some individuals. Qualifications — Education & Experience Education Bachelor's degree in a life sciences-related field. Experience Minimal clinical monitoring experience sufficient to perform the role, described as comparable to approximately 2 years. Relevant experience may come from clinical trials, medical terminology, medical research, clinical research, healthcare, or a health sciences field with formal training in medical terminology and anatomy. Valid driver's license where applicable. An appropriate combination of education, training, and directly related experience may be accepted as an equivalent qualification. Knowledge, Skills & Abilities The position requires: Basic medical/therapeutic-area knowledge and understanding of medical terminology. Ability to attain and maintain working knowledge of ICH-GCP, applicable regulations, and procedural documents. Good oral and written communication skills, including communication with medical personnel. Good interpersonal skills. Customer focus, listening skills, attention to detail, and ability to identify underlying customer issues. Good organizational and time-management skills. Flexibility and adaptability across different situations. Well-developed critical thinking, investigation, root cause analysis, and problem-solving skills. Ability to manage Risk-Based Monitoring (RBM) concepts and processes. Ability to work independently or as part of a team. Good computer skills, including solid Microsoft Office knowledge and ability to learn relevant software. Good English language and grammar skills.
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: As a Field Service Engineer at Thermo Fisher Scientific, you'll contribute to delivering excellent service for sophisticated analytical and scientific instruments. Working with customers across research, industrial, and healthcare settings, you'll install, maintain, troubleshoot, and repair complex equipment while providing exceptional customer service. This position offers opportunities to work with advanced technology while contributing to scientific advancement and innovation. REQUIREMENTS: • Advanced Degree, no prior experience required, or Bachelor's Degree plus 2 years of hands-on technical experience installing, troubleshooting and repairing complex analytical instruments • Preferred Fields of Study: Electronics, Engineering, Physics, Chemistry, or related technical field • Additional relevant certifications are advantageous • Strong electronics and mechanical troubleshooting skills with ability to diagnose issues down to component level • Experience with ultra-high vacuum systems and high voltage equipment preferred • Excellent customer service and communication skills, both written and verbal • Strong organizational and time management capabilities • Proficiency with Microsoft Office suite and service management software • Ability to read and interpret technical documentation and schematics • Valid driver's license and ability to travel up to 50-75% within assigned territory • Physical ability to lift up to 50 lbs and work in various laboratory environments • Proficiency in English required; additional languages beneficial • Strong problem-solving abilities and capacity to work independently • Adherence to safety protocols and quality standards • Ability to respond to customer needs with short notice • Ability to effectively train and support customers on equipment operation • Experience documenting service activities and preparing detailed reports • Demonstrated success in meeting customer satisfaction goals