Bulgaria · Remote Solely
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Clinical Team Manager - Make an Impact at the Forefront of Innovation The Senior Clinical Trial Manager is accountable …
Skills: Clinical trial management, ICH GCP, Project management, Leadership, Mentoring
Vilnius, Vilnius County, Lithuania · On-site
$1k–$2k/mo
Work Schedule Standard (Mon-Fri) Environmental Conditions Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Apie „Thermo Fisher Scient…
Skills: Laboratory equipment maintenance, Dishwashing, Inventory management, Documentation, Quality control
Suzhou, Jiangsu, China · 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: Project management, Clinical trials, Budget management, Client relations, Risk management
Carlsbad, California, United States · On-site
$114k–$151k/yr
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: Program management, Oncology, Companion diagnostics, Next generation sequencing, Regulatory submission
Bengaluru, Karnataka, India · Hybrid
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: ServiceNow CSM, JavaScript, Glide APIs, Business Rules, Client Scripts
Mumbai City, Maharashtra, India · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as Associate Medical Writer – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutica…
Skills: Medical writing, Scientific writing, Clinical trials, Regulatory documentation, Drug development process
Linz, Upper Austria, Austria · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Bei Thermo Fisher Scientific erwartet Sie eine sinnvolle Arbeit, die weltweit…
Skills: GMP, Quality Management, Production, Regulatory Compliance, Documentation
Lebanon, Tennessee, United States · On-site
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facia…
Skills: Manufacturing, Assembly, Packaging, Cleanroom protocols, Standard Operating Procedures
Taipei, Taiwan · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description POSITION SUMMARY This role is a strategic opportunity identifier and developer. The core mission is to identify and qualify high-potential …
Skills: Sales Development, Lead Qualification, Cold Calling, Technical Sales, Customer Engagement
Mumbai City, Maharashtra, India · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As a Field Application Scientist, you will support our customers on technical applications and training in the field, within the Chemical A…
Skills: Chemical analysis, XRF, XRD, Optical emission spectroscopy, Technical support
Horsham, England, United Kingdom · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description How will you make an impact: By being part of the team at Thermo Fisher, you’ll do outstanding and life changing work, like helping custome…
Skills: Order processing, Compliance, SOP adherence, Data entry, Communication
Freiburg im Breisgau, Baden-Württemberg, Germany · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting Job Description Thermo Fisher Scientific Inc. ist das weltweit führende Unternehmen im Dienste der Wissenschaft mit einem Jahresumsatz von rund…
Skills: Laboratory cleaning, Equipment monitoring, Waste disposal, GMP documentation, Autoclaving
Irvine, California, United States · Remote OK
$112k–$169k/yr
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: Mass spectrometry, Technical sales, Account management, Strategic planning, Sales forecasting
Prague, Prague, Czechia · On-site
Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Office Job Description Join Us a a Medical Director – Make an Impact at the Forefront of Innovation! At Thermo Fisher Scientific, you’ll discover meaningful wo…
Skills: Clinical trials, Medical oversight, Pharmacovigilance, Regulatory compliance, Internal medicine
Paris, Ile-de-France, France · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Director, Digital Marketing – EMEA Life Sciences Location: Office base Scotland - UK, Paris - France, Madrid - Spain, Darmstadt - Germany, …
Skills: Digital Marketing, Marketing Strategy, Data-Driven Marketing, Marketing Transformation, Customer Lifecycle Marketing
Guangzhou, Guangdong, China · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fish…
Skills: Manufacturing, Operations, Production, Laboratory procedures, Cgmp compliance
Guangzhou, Guangdong, China · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fish…
Skills: Manufacturing, Operations, Production, Laboratory procedures, cGMP
Basingstoke, England, United Kingdom · On-site
Work Schedule Rotational shift days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, na…
Skills: Mechanical troubleshooting, Electrical troubleshooting, Instrument calibration, CAD software, Preventative maintenance
Mumbai City, Maharashtra, 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: Practical Process Improvement, Lean Methodologies, Six Sigma, Strategy Deployment, Value Stream Mapping
Linz, Upper Austria, Austria · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Bei Thermo Fisher Scientific erwartet Sie eine sinnvolle Arbeit, die weltweit…
Skills: Process Validation, Continued Process Verification, GMP, Statistical Analysis, Chemical Engineering
Bulgaria • Remote Solely
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The Senior Clinical Trial Manager is responsible for managing all clinical operational and quality aspects of studies to ensure deliverables meet time, quality, and cost expectations. They lead clinical teams, manage project financials, and ensure compliance with ICH GCP and regulatory standards throughout the study lifecycle.
Candidates must hold a bachelor's degree or equivalent and possess approximately 8 or more years of relevant experience in clinical trial management. Strong leadership, organizational, and financial management skills are required, along with an in-depth understanding of clinical monitoring practices and regulatory guidelines.
Join Us as a Senior Clinical Team Manager - Make an Impact at the Forefront of Innovation
The Senior 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. Interprets data on complex issues and makes good business decisions with support from line management. The role involves working to ensure that all clinical deliverables meet the customer's time/quality/cost expectations, and maintaining profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically the Senior Clinical Trial Manager works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.
We are looking for experienced Sr CTMs with previous experience in the role and preferably experience in the Start Up Team Manager role. Previous experience in non-interventional / Phase IV studies is also preferable
What You'll Do:
• Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities, e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.
• 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 leads 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 clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• 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 ensure that essential document quality meets the expectation of Regulatory Compliance Review. Ensure timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibility may vary based on project timelines.
• 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.
• In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities.
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 8+ 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:
• Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
• Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization
• Solid understanding of change management principles
• Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
• Strong judgment, decision making, escalation, and risk management skills
• Effective oral and written communication skills, including English language proficiency
• Capable of evaluating own and team members workload against project budget and adjust resources accordingly
• Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
• Strong attention to detail
• In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Capable of independently managing clinical only studies.
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
