Thermo Fisher Scientific

Operations

• Contribute to the proposal development process from receipt through client decision to increase RFP hit rate and support business growth
• Recommend and implement operational strategies for proposals and bid defenses
• Manage proposal-related deliverables and the overall proposal process
• Lead RFPs and supplemental documents for single- or multi-service/region clinical development protocols or programs and simple-to-moderate RFIs
• Identify and recommend operational proposal strategic plans aligned with commercial win strategy
• Determine proposal deliverables and key operations messages
• Manage the clinical operations triage process to meet proposal deliverables
• Ensure budgets reflect operational strategy and oversee profitability targets
• Partner with Clinical Operations, Commercial, and GPD to improve proposal efficiency and decrease COS
• Drive development of the operations segment of proposal deliverables within timelines
• Communicate operational strategy to the proposal team and develop KPIs
• Collaborate with cross-functional teams in a matrix environment
• Manage operations escalations and advise the commercial strategy team
• Assess cross-functional satisfaction and recommend future strategies and actions
• Recommend and implement Clinical Operations revisions post-award to support successful proposal execution

Operations Strategy Consultant – FSP Team

Assistant

• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
• Support site preparedness and the monitoring process
• Assist with site management and remote monitoring tasks in accordance with SOPs and regulatory guidelines
• Complete study and site management activities defined in the task matrix
• Complete and document study-specific training and orient to study-specific systems
• Provide in-house support during pre-study assessments and assessment waivers
• Customize site ICFs with site contact details as needed
• Perform remote EMR/EHR checklist reviews and support applicable assessments
• Verify document collection and RCR submission status; update site EDL and site information
• Review patient-facing materials and translations
• Support vendor qualification, site-system access, site staff training, IM attendance logistics, vendor trackers and study/site supplies
• Support Essential Document collection, review and updating in systems
• Follow up on missing vendor data, including ECGs, lab samples and e-diaries
• Support ongoing remote review of centralized monitoring tools
• Coordinate site payments, system updates, reconciliations and site invoice follow-up
• Perform reconciliation tasks involving CRF and query status, deviations, SAEs and safety reports
• Drive action for missing, incomplete or expired documents and open document findings
• Perform other assigned site management tasks and client-requested FSP role profiles
• Complete administrative tasks including expense reports and timesheets
• Occasional travel to clinics or hospitals may be required

Assistant CRA

Clinical Research

• Coordinate, oversee and complete assigned trial activities according to the task matrix
• Perform department, internal, country and investigator file reviews and document findings
• Ensure allocated tasks are completed on time, within budget and to a high-quality standard
• Communicate project risks to project leads and line manager
• Maintain study-specific documentation, team lists, training trackers, system access management and project activity plans
• Keep the electronic Trial Master File (eTMF) up to date and document review findings
• Provide system support, including GoBalto and eTMF
• Support risk-based monitoring (RBM) activities
• Process documents for the client eTMF, perform eTMF reviews, mass mailings and communications, and provide reports to internal team members
• Schedule and organize client/internal meetings and complete meeting minutes
• Review and track local regulatory documents
• Transmit documents to the client and centralized IRB/IEC
• Analyze and reconcile study metrics and findings reports
• Assist with clarification and resolution of site-documentation findings
• Maintain vendor trackers
• Coordinate, compile and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies to sites
• Assist with study-specific translation materials and translation quality control
• Attend kick-off meetings and take notes when required
• Act as a cross-functional liaison and potential study lead
• Support onboarding as a buddy and train new staff as needed
• Support departmental and cross-functional process-improvement initiatives

Trial Delivery Specialist – Clinical Trial Coordinator

• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
• Support site preparedness and logistical monitoring processes
• Assist with site management and remote monitoring according to SOPs and regulatory guidelines
• Perform limited site contact activities during study start-up, site management, recruitment, and close-out
• Complete study and site management activities defined in the task matrix
• Complete study-specific training and orientation on study systems
• Provide in-house support for pre-study assessments and waivers
• Customize site ICFs with site contact details
• Review EMR/EHR checklists remotely
• Verify document collection, RCR submission status, site EDL, and site information
• Review patient-facing materials and translations
• Support vendor qualification, system access, site staff training, IM attendance, vendor trackers, and study/site supplies
• Support essential document collection, review, and updating
• Follow up on missing vendor data, including ECGs, lab samples, and e-diaries
• Support remote review of centralized monitoring tools
• Support site payment processes, system updates, reconciliations, and invoice follow-up
• Perform trial reconciliations involving CRF/query status, deviations, SAEs, and safety reports
• Drive action for missing, incomplete, expired, or open documents
• Complete administrative tasks including expense reports and timesheets

Assistant CRA – Northeast/Southeast

Account Manager

• Support revenue growth and contribute to serving science
• Develop and maintain strategic customer relationships
• Promote Thermo Fisher Scientific's portfolio of innovative products and services
• Implement sales strategies
• Identify new business opportunities
• Provide customer support to help customers achieve their goals
• Represent Thermo Fisher Scientific's scientific solutions

Account Manager II – Healthcare Market Division

• Function independently as a lead statistician with minimal oversight
• Deliver project statistician tasks, including analysis database creation, statistical analyses, and formatted statistical analysis tables and summaries
• Provide mentorship and guidance to junior team members
• Ensure compliance with departmental SOPs and established statistical analysis and programming procedures
• Lead project teams, conduct team meetings, maintain project timelines, assess resource requirements, allocate resources, and prepare project budgets
• Interact directly with sponsors on statistical aspects of assigned projects
• Coordinate with programmers and data management personnel on database maintenance, updates, and documentation
• Provide guidance on database structures required for statistical analyses
• Perform sample size calculations and review protocols for clinical study design and statistical methodology
• Develop randomization schemes and associated documentation
• Develop statistical analysis plans, analysis database specifications, and table and listing specifications
• Program and/or validate statistical tables, especially efficacy endpoints, and oversee related programming and validation activities
• Review reports, documents, and manuscripts; contribute to statistical methods sections and verify statistical completeness and consistency
• Monitor project budgets and communicate potential scope changes to management
• Provide departmental infrastructure support through presentations, training, departmental documents and policies, newsletters or libraries, and onboarding support

Biostatistician II

Contract Specialist

• Manage preparation, negotiation and finalization of the contracts process
• Liaise with study sites and internal functional teams
• Draft, review, negotiate and finalize agreements with study sites
• Negotiate investigator grant budgets and contractual terms within approved parameters
• Ensure compliance with negotiation parameters, approvals, contractual processes, budgetary guidance, templates and client expectations
• Identify and assess legal, financial and operational risks and escalate issues appropriately
• Provide recommendations and alternative resolutions for Investigator Contracts negotiations
• Coordinate site startup activities with internal departments and align them with contractual activities and site activation timelines
• Achieve target cycle times for site activations
• Track and report activities as required
• Train and mentor junior staff
• Participate in country process improvement initiatives and country team meetings
• Act as country subject matter expert for Investigator Contracts training materials
• Liaise with Global Site Contracts to ensure compliance with global processes and corporate directives
• Complete periodic quality reviews and peer feedback reports
• Lead amendment/novation client projects and oversee confidentiality agreement negotiations when required
• Manage responsibility for Germany, Austria and Switzerland

Senior Contract Specialist

• Draft, review, negotiate and finalize agreements with study sites
• Negotiate investigator grant budgets, contractual terms and conditions within approved parameters
• Manage site contracts and budget negotiations in Germany, Austria and Switzerland
• Ensure compliance with negotiation parameters, approvals, contractual processes, budgetary guidance, templates and client expectations
• Identify, assess and escalate legal, financial and operational risks
• Provide recommendations and alternative resolutions for Investigator Contracts negotiations
• Coordinate with internal functional departments on site startup and contractual activities
• Align contract negotiations with study timelines and site activation critical paths
• Achieve target cycle times for site activations
• Track and report activities as required
• Train and mentor junior staff
• Participate in country process improvement initiatives
• Serve as country subject matter expert for Investigator Contracts training materials
• Liaise with Global Site Contracts to ensure compliance with global processes and corporate directives
• Complete periodic quality reviews and peer feedback reports
• Lead amendment/novation client projects and oversee confidentiality agreement negotiations

Senior Site Contract Specialist

Manager

• Design, develop, and validate AI/ML and NLP components supporting safety operations, including auto-coding, case triage, duplicate detection, and narrative summarization
• Contribute to safety-relevant AI/ML model lifecycle management, including versioning, monitoring, drift detection, retraining, and documentation
• Support qualification of AI/ML solutions against regulatory expectations in partnership with Quality, DT/BIS, and GPS Signal Management
• Serve as the key technical resource for configuration, maintenance, and administration of the Oracle Argus Safety system
• Support day-to-day operation and troubleshooting of safety systems
• Assist with system validation, testing, and deployment of safety-system updates
• Generate, validate, and customize safety reports and analytics
• Collaborate with pharmacovigilance, clinical, regulatory, client, internal systems, BIS/DT, and vendor teams
• Participate in change management to enhance safety-system integrations
• Contribute to audit readiness, inspections, validation reports, and compliance documentation
• Generate and quality-control aggregate reports and line listings
• Develop procedural documents, including Safety Management Plans, SOPs, work instructions, job aids, forms, and templates
• Stay current on regulatory and pharmacovigilance technology guidelines and share updates
• Participate in safety data management training
• Review processes and tools and recommend efficiency improvements
• Lead GPS Safety Data Management and Safety System Maintenance deliverables
• Provide high-quality data outputs for Safety Signal Management, Risk Management, and Safety Evidence generation
• Complete additional tasks and projects assigned by the line manager or delegate

Associate Manager, Safety Data and Systems – Pharmacovigilance

Procurement

• Manage vendor partnerships supporting Physical AI data collection programmes, including egocentric capture, sensor-tagged spatial data, and on-the-ground activity datasets
• Understand off-the-shelf data requirements and work with vendors to assess fitness-for-purpose, licensing constraints, and data provenance
• Coordinate multi-site or multi-country data collection engagements
• Serve as the operational bridge between internal data science/product teams and external vendor partners on collection protocols, tooling requirements, and delivery timelines

Vendor Management Specialist

AI Research Scientist

• Run researcher, AI architect, and leadership searches end to end, from intake through close
• Size the market before outreach with a defensible success profile, realistic obtainable segment, and named target map
• Own the offer narrative for candidates holding cash and public equity
• Coach hiring managers and panels on structured evaluation and calibration
• Use AI deliberately in recruiting workflow and help decide what to automate, augment, or keep human
• Create market briefs, calibration notes, and lasting relationships to improve future searches
• Help enable a research organization competing at the front of AI research, including conference-quality work, lab and university partnerships, foundation-model and agentic-AI breakthroughs, and customer-facing research

Senior Recruiter, AI Research & Leadership

• Manage and optimize drug safety operations for clinical trials
• Manage contractual, procedural, and regulatory requirements across local and global projects
• Maintain communication with functional groups regarding program and company issues
• Collaborate on problem solving and systems improvement
• Review pharmacovigilance publications and information sources to stay current on regulations, practices, procedures, and proposals
• Maintain basic medical understanding of applicable therapeutic areas and disease states
• Participate in on-call duties and ensure 24-hour case-intake coverage when required
• Provide project plans and accurate forecasts
• Serve as a resource for departmental managers and lead departmental initiatives
• Prepare and present proposals
• Manage experienced professional staff, including hiring, development, performance management, coaching, counseling, and separations
• Approve salary administration, hiring, corrective action, terminations, time records, expense reports, leave requests, and overtime

Pharmacovigilance Manager

• Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
• Assume Clinical Study Manager responsibilities on small or less complex projects when required
• Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to data quality and master action plans
• Set up, organize, maintain, and archive relevant Trial Master File sections and study materials
• Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
• Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings
• Lead clinical team meetings and coordinate with clinical and cross-functional teams to maintain timelines, resources, quality, and interactions
• Implement and train standardized clinical monitoring processes
• Monitor clinical activity timelines and metrics, provide status updates, review projects and monitoring visit reports, implement recovery actions, and manage CRF collection and query resolution
• Conduct or co-monitor clinical trials and assess performance against contractual obligations
• Conduct Accompanied Field Visits and manage project financials in smaller regions when required
• Communicate with study sites regarding protocols, patient participation, case report forms, and study issues
• Coordinate study start-up activities and ethics committee and regulatory submissions when required
• Review and follow up on ethics committee questions and ensure essential document quality
• Provide input into clinical activity forecasts and manage clinical resources, responsibilities, delegation, and additional resource requirements

Clinical Team Manager

Infrastructure Engineer

• Collaborate with the Cloud service team, internal teams, and cloud vendors to support infrastructure delivery and deployment activities
• Perform operating system reinstallation and reboot for cloud servers and bare metal environments
• Troubleshoot infrastructure issues involving Linux systems, cloud servers, networking, and hardware-related abnormalities
• Maintain operational data across internal systems including fault ticketing systems, repair records, and infrastructure tracking tools
• Work with cloud providers to resolve infrastructure incidents and large-scale operational issues
• Participate in on-call rotations and support incident management activities
• Monitor cloud infrastructure health, operational alerts, and asset utilization
• Develop or enhance operational tools, scripts, and automation workflows using Shell or Python
• Support operational process optimization and standardization initiatives
• Perform server and cloud network troubleshooting, including TCP/IP, VLAN, DNS, and IPv6 related issues
• Support cloud fleet operations and infrastructure performance management
• Assist with documentation creation, knowledge sharing, and operational reporting

Cloud Infrastructure Operations Engineer

Human Resources

• Serve as a strategic partner to business and functional leaders
• Translate business priorities into people strategies that accelerate growth and strengthen organizational performance
• Work closely with global leadership to turn strategy into action
• Build organizational capabilities and develop innovative HR solutions
• Lead change and help attract, develop, engage and retain outstanding talent
• Partner with leaders to develop HR and talent strategies aligned with business priorities
• Advance company culture and build capabilities for high-performing, diverse talent
• Use HR analytics, business insights and external market trends to identify opportunities and shape talent strategies
• Connect people decisions to measurable business outcomes and organizational performance
• Advise and coach senior leaders on complex organizational and people matters
• Support talent development, succession, engagement, performance and employee relations
• Lead organizational design, development and culture initiatives
• Help leaders and teams navigate change while reinforcing Thermo Fisher Scientific’s 4i Values
• Build partnerships across the global HR organization
• Coordinate HR Business Partners and Centers of Excellence to deliver consistent solutions
• Lead HR priorities and strategic initiatives from concept through implementation
• Balance competing priorities, coordinate resources and simplify and continuously improve work processes