Changsha, Hunan, China · Remote Solely
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: Clinical Monitoring, Problem Solving, Critical Thinking, Data Accuracy, Regulatory Compliance
Taipei, Taiwan · Remote OK
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, Site Activation, Regulatory Compliance, ICH GCP
South San Francisco, California, United States · On-site
$20/hr–$30/hr
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold R…
Skills: RF Handheld Scanners, Inventory Control, Microsoft Office, English Communication, Stock Rotation
Limonest, Auvergne-Rhône-Alpes, France · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description DESCRIPTION Thermo Fisher Scientific’s Microbiology Division (MBD) is seeking a highly motivated Account Manager to manage and grow a large…
Skills: Account Management, Business Development, Tender Management, CRM Salesforce, Relationship Building
Stafford Springs, Connecticut, United States · On-site
$103k–$138k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)…
Skills: EHS Management, Regulatory Compliance, Incident Prevention, Risk Assessment, Root Cause Analysis
Vilnius, Vilnius County, Lithuania · On-site
$2k–$2k/mo
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Pareigų aprašymas Šiuo metu ieškome Jaunesniojo (-sios) chemiko (-ės) prisiju…
Skills: Ribonucleotide Production, Deoxynucleotide Production, Chromatographic Purification, Formulation, GMP Compliance
Shanghai, Shanghai, China · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Position Summary The Senior Commercial Manager is responsible for driving business growth and commercial excellence in China by leading the…
Skills: Commercial Strategy, Business Planning, Forecasting, Market Development, Sales Leadership
Grand Island, New York, United States · On-site
$14/hr–$21/hr
Work Schedule Second Shift (Afternoons) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup…
Skills: Communication, Multitasking, cGMP, Material Repacking, Inventory Retrieval
Cambridge, Massachusetts, United States · On-site
$19/hr–$29/hr
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 Pay Range: $19.64 to $27.1…
Skills: Inventory Management, Order Management, Customer Service, Microsoft Office, Data Entry
Chelmsford, Massachusetts, United States · On-site
$19/hr–$29/hr
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glas…
Skills: Microbiology, Environmental Monitoring, Endotoxin Testing, Bioburden Assay, LAL Method
Dallas, Texas, United States · Remote OK
$96k–$128k/yr
Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Office Job Description Thermo Fisher Scientific’s Clinical Diagnostics business is committed to enabling customers to improve patient care through innovative d…
Skills: Immunoassay Systems, Assay Validation, Technical Troubleshooting, Clinical Laboratory Operations, Customer Training
Budapest, Central Hungary, Hungary · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as Manager Clinical Operations - FSP – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 phar…
Skills: Clinical Trial Monitoring, Leadership, Mentoring, Performance Management, ICH/GCP
Buenos Aires, Argentina · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation The Senior Country Approval Specialist mana…
Skills: Regulatory Submissions, Local Regulatory Strategy, SIA Services, Clinical Trial Coordination, Documentation Quality
Manila, Metro Manila, Philippines · Hybrid
Work Schedule Second Shift (Afternoons) Environmental Conditions Office Job Description Join Us as a Clinical Review Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 ph…
Skills: Clinical Data Review, Good Clinical Practice (GCP), Data Validation, Pharmaceutical Terminology, Interpersonal Skills
Morrisville, North Carolina, United States · 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: Strategic Sourcing, Category Management, Contract Negotiation, Supplier Relationship Management, Spend Analysis
Warrington, England, United Kingdom · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail …
Skills: People Management, cGMP Regulations, Project Management, Statistical Process Control, FMEA
Greenville, North Carolina, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Discover Impactful Work: Join Thermo Fisher Scientific and be part of…
Skills: Process Validation, Cleaning Validation, Equipment Qualification, IQ/OQ/PQ, Aseptic Manufacturing
Brno, Southeast, Czechia · 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 Engineering, Requirements Management, Architecture Development, Python, MATLAB
Sofia, Sofia-City, Bulgaria · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Principal Safety Report Specialist – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, you’ll discove…
Skills: Safety Reporting, Project Management, Medical Terminology, Microsoft Office, Regulatory Compliance
West Greenwich, Rhode Island, United States · 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: Work Order Management, Customer Service, CMMS, Vendor Coordination, Technical Training
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The role involves performing and coordinating clinical monitoring and site management processes, ensuring compliance with protocols and regulations. Responsibilities include conducting remote or on-site visits, managing documentation, and developing relationships with investigational sites.
Candidates should have a bachelor's degree in a life sciences field or equivalent qualifications, along with proven clinical monitoring skills. A minimum of one year of relevant experience or completion of a fellowship is preferred.
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.
Summarized Purpose:
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Key responsibilities
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.
Keys to Success
Education and Experience:
Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable.
Knowledge, Skills and Abilities:
Proven clinical monitoring skills.
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes.
Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues.
Good organizational and time management skills
Effective interpersonal skills.
Attention to detail.
Ability to remain flexible and adaptable in a wide range of scenarios.
Ability to work in a team or independently as required.
Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
Good English language and grammar skills.
Good presentation skills.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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
