Thermo Fisher Scientific

Clinical Operations

• Manage and conduct induction/orientation programs for new employees
• Ensure all training records and profiles are complete and up-to-date
• Support allocation activities per the local resourcing process
• Escalate project deliverable issues appropriately
• Deliver training on WPDs and SOPs
• Identify training gaps and meet training requirements
• Contribute to development of training programs
• Participate in process improvement initiatives
• Manage and review project systems to evaluate metrics and status
• Conduct evaluations of staff performance and project conduction
• Manage staff through interviews, coaching, performance management, etc.
• Review and approve time records and expense reports

FSP Clinical Operations Manager

Compliance

• Develops study-specific import/export trade compliance plans
• Coordinates with internal teams on project activities
• Ensures communication between departments to avoid obstacles
• Integrates trade compliance with supply chain activities
• Participates in training on new regulations

Senior Trade Compliance Manager

DevOps Engineer

• Develop and manage CI/CD pipelines
• Automate infrastructure provisioning and configuration
• Monitor application and infrastructure health
• Ensure system security and compliance
• Collaborate with cross-functional teams to streamline deployments

Manager

• Accountable for achieving the final clinical deliverable
• Ensures compliance with ICH GCP and applicable regulations
• Develops clinical tools and study plans
• Manages all aspects of monitoring operations and quality for assigned studies
• Serves as clinical subject matter expert
• Ensures timely deliverables, monitors trials, coordinates activities

Clinical Team Manager – Senior

Medical Director

• Provides medical oversight of clinical trials
• Attends and presents at investigator and sponsor meetings
• Provides medical consultation to clients, investigators, and project team members
• Monitors safety variables of clinical studies
• Reviews adverse events of special interest
• Contributes to departmental process improvement initiatives
• Assists in writing/review of regulatory documents

Associate Medical Director – Hematology/Oncology

Frontend Engineer

• Collaborate closely with UX/UI designers to transform designs into functional components
• Ensure components are optimized for performance and compatibility
• Attend daily stand-ups to align with the team
• Code reusable, accessible, and adaptable UI components
• Conduct accessibility tests to meet WCAG standards
• Update documentation with usage guidelines and examples
• Review implementations to ensure they align with the design system consistently
• Plan and prioritize next steps to improve scalability and user experience

UX Engineer

• Support the Clinical Trials Division of the Pharma Services Group (PSG) of Thermo Fisher Scientific, by negotiating a variety of customer facing agreements globally
• Draft and negotiate both routine and non-routine contractual agreements
• Interface collaboratively with internal partners and customers to influence and provide direction to guide the contracting process
• Continually strive to make the contracting process more efficient, effective, and customer centric
• Serve as the main liaison between the client and the manufacturing sites and business units in North America during the contract negotiation phase of a project
• Mentor and develop team members
• Build successful work environments and provide support and mentorship to your team ensuring high levels of performance

Senior Manager, Contracts

Accountant

• Support the corporate close process, including preparation and review of journal entries, rollforwards, account reconciliations, and variance analyses across more than 10 entities
• Collaborate with regional finance teams to guarantee adherence to group reporting schedules and accounting policies
• Establish new Intercompany relationships and set up accurate eliminations as sites move into Thermo Fisher systems
• Work with E&Y to supervise the settlement process that will last through the 24-month TSA (Transition Services Agreement) period across 25 entities
• Support external and internal audits by preparing schedules, reconciliations, and documentation
• Participate in ERP integrations as the business exits the TSA, including onboarding new entities and transitioning accounting tasks to the shared service center
• Support ad-hoc internal, group, and corporate requests as needed
• Challenge current processes to identify improvement opportunities
• Work closely with key business partners to identify and mitigate issues impeding the achievement of business goals
• Ensure business transactions continue to be in accordance with generally accepted accounting principles, policies, and SOX controls

Senior Accountant – Reporting

Account Manager

• Support revenue growth and serve science
• Develop and maintain strategic relationships with customers
• Promote a comprehensive portfolio of innovative products and services
• Implement sales strategies and identify new business opportunities
• Provide excellent support to help customers achieve their goals
• Represent a leader in scientific solutions and contribute to their mission

Account Manager II

Project Manager

• Serve as the Global Project Lead embedded with the sponsor team.
• Ensure escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways).
• On projects where the scope requires, ensure clear delineation in responsibilities and communication pathways for secondary project leads.
• Accountable for the overall delivery of the cross-functional project (time, cost, quality).
• Ensure financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget.
• Manage Out-of-Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
• Establish, communicate and manage customer expectations to achieve optimal delivery.
• Drive Risk Identification and Issue Resolution at project level.
• Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Global Project Manager – Study Close-out, FSP

• Collaborate with team members to ensure effective site activation
• Oversee site activation according to timelines and quality standards
• Manage technical and operational aspects, including feasibility, site selection, and contracts coordination
• Provide quality checks for EC submission packages

Start Up Team Manager, FSP

Medical writer

• Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
• Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
• Develops and updates standard medical response documents, custom response documents, frequently asked questions, and formulary dossiers.
• Researches and responds to escalated medical information inquiries from healthcare providers.
• Conducts literature searches for standard response documents utilizing secondary databases.
• Integrates pertinent clinical data into standard response documents with clear, concise, accurate and balanced medical writing.
• Participates as required in project launch meetings, review meetings, and project team meetings, serving as a liaison for communication with the client.
• Collaborates and effectively communicates with internal and external client contacts to provide high quality medical information writing deliverables in a timely manner and within budget.

Medical Writer – Medical Information

Program Manager

• Lead client programs with high visibility among internal and client teams
• Manage client relationships and identify and resolve client management issues
• Ensure the timely delivery and the quality of multiple program documents
• Develop, monitor, and adapt project plans, client and program-specific processes, timelines, and budgets/forecasting for programs
• Serve as subject matter expert for assigned programs

Program Manager – Regulatory Medical Writing

• 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
• 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

Senior Clinical Team Manager – Internal Medicine

Full-stack Engineer

• Design and develop software for laboratory automation applications with an emphasis on quality, security, performance, and scalability
• Collaborate with product owners and customers to identify and refine requirements for new features
• Work with our quality assurance, documentation, training and service teams to deliver an excellent customer experience