Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation The Clinical Trial Manager is accountable for achieving…
Skills: Clinical Trial Management, ICH GCP, Clinical Monitoring, Project Management, Budgeting and Forecasting
Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate I – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharma…
Skills: Clinical Monitoring, ICH-GCP Guidelines, Risk-Based Monitoring, Root Cause Analysis, Site Management
Kuala Lumpur, Kuala Lumpur, Malaysia · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceu…
Skills: Clinical Trial Coordination, eTMF Management, ICH GCP, Project Coordination, Regulatory Documentation
Kwai Chung, Hong Kong, China · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Summary We are seeking a proactive and tech-savvy Assistant Manager to support the management of our Distribution Center (DC) operation…
Skills: Logistics Management, Data Analysis, Digital Transformation, Warehouse Operations, Power BI
Hyderabad, Telangana, India · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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 coll…
Skills: SolidWorks, MCAD Modelling, GD&T, ASME Y14 Standards, Sheet Metal Design
Bengaluru, Karnataka, India · Remote OK
Work Schedule Other Environmental Conditions Office Job Description Summarized Purpose: We are presenting an outstanding opportunity to join Thermo Fisher Scientific as a Sr Systems Developer. In this role, you will play…
Skills: SQL Server, AWS, Python, PySpark, ETL
Newport, Wales, United Kingdom · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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 coll…
Skills: Systems Analysis, Business Analysis, SDLC, Project Management, Requirement Gathering
Ireland · Remote Solely
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Data Reviewer- Remote, Pharma At PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a g…
Skills: Analytical Data Review, Chromatography, GMP Compliance, GLP Compliance, SOP Adherence
Vilnius, Vilnius County, Lithuania · On-site
$2k–$3k/mo
Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting Job Description Pareigų aprašymas Šiuo metu ieškome Kokybės kontrolės analitiko (-ės) prisijungti prie mūsų komandos. Šioje pozicijoje būsite a…
Skills: PCR, Quantitative PCR, DNA/RNA Electrophoresis, SDS-PAGE, Molecular Biology Methods
Sofia, Sofia-City, Bulgaria · Remote OK
Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate I – Make an Impact at the Forefront of Innovation We have successfully supported the to…
Skills: Clinical Monitoring, ICH-GCP, Risk-Based Monitoring, Root Cause Analysis, Site Management
Bremen, Bremen, Germany · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Will work with haza…
Skills: Product Management, Market Analysis, Product Lifecycle Management, Competitive Analysis, Microsoft Excel
Bengaluru, Karnataka, India · Remote OK
Work Schedule Other Environmental Conditions Office Job Description Summarized Purpose: Join our innovative team as a Systems Dev Spec and make a meaningful impact on global science and healthcare. In this role, you'll d…
Skills: Java, Spring Boot, AWS, Azure, SQL
Taguig, Metro Manila, Philippines · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Standing for full shift Job Description Join Us as a Site Payments Associate II - Make an Impact at the Forefront of Innovation As a Site Payments Associate II yo…
Skills: Data Compilation, Financial Reconciliation, Contractual Compliance, Relationship Management, MS Excel
Sofia, Sofia-City, Bulgaria · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringin…
Skills: Oracle ERP, PPM Module, CA Clarity PPM, Financial Reporting, Data Integrity
Munich, Bavaria, Germany · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Facilities Coordinator II As part of the Thermo Fisher scientific team, you will discover meaningful work that makes a positive impact on a…
Skills: Facilities Coordination, Vendor Management, Health and Safety Compliance, Office Management, Project Coordination
Norway · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate I – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharma…
Skills: Clinical Monitoring, ICH-GCP, Risk-Based Monitoring, Root Cause Analysis, Site Management
Taguig, Metro Manila, Philippines · Hybrid
Work Schedule Third Shift (Nights) Environmental Conditions Office Job Description As part of our PPD clinical research team, you’ll have the opportunity to support groundbreaking studies that make a real difference in p…
Skills: Medical Information, Adverse Event Reporting, Product Complaint Handling, Customer Service, Clinical Trial Support
Budapest, Central Hungary, Hungary · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll do meaningful work that helps make the world healthier, cleaner and safer. As part of a global organiza…
Skills: People Management, Coaching, Team Development, Customer Service, Analytical Skills
Paisley, Scotland, United Kingdom · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Position Summary: Thermo Fisher Scientific have an excellent opportunity for an individual to join the External Reporting Team. This is an …
Skills: Statutory Reporting, Management Accounting, Balance Sheet Reconciliations, Tax Compliance, Financial Statement Preparation
Vilvoorde, Flanders, Belgium · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Standing for full shift, Warehouse, Will work with hazardous/toxic materials Job Description Join Us as a Logistics Coord…
Skills: Attention To Detail, Computer Skills, Time Management, Data Entry, Critical Thinking
Kuala Lumpur, Kuala Lumpur, Malaysia • Hybrid
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Accountable for achieving final clinical deliverables and clean data within contractual timelines and budgets. Manages operational and quality aspects of oncology studies, including the development of monitoring plans and coordination of clinical teams.
Requires a bachelor's degree or equivalent with at least 5 years of relevant experience in clinical trial management. Must possess strong knowledge of ICH/GCP guidelines, leadership skills, and proficiency in clinical monitoring processes.
Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
What You'll Do:
• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
• May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
• May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• Good planning and organizational skills to enable effective prioritization of workload
• Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
• Capable of working effectively in a changing environment with complex/ambiguous situations
• Familiarity with the practices, processes, and requirements of clinical monitoring
• Good judgment and decision making skills
• Effective oral and written communication skills, including English language proficiency
• Capable of evaluating workload against project budget and adjusting resources accordingly
• Sound financial acument and knowledge of budgeting, forecasting and fiscal management
• Strong attention to detail
• Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
