TMF Lead Job at iconplc (Warsaw)

Clinical Site Associate (In-House CRA)

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Turkey , Ankara

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field, such as life sciences or healthcare
Previous experience in clinical research or a related field preferred
Strong organizational and communication skills
Ability to work independently and collaboratively in a fast-paced environment
Attention to detail and ability to prioritize tasks effectively
Fluent in English and local language, with good verbal and written communication skills

Job Responsibility

Site Support & Oversight: Manage site-level communications, coordinate site trainings and systems access, and support site readiness activities including pre/post site visit tasks, and follow-up on action items
Document Management: Maintain Trial Master File (TMF) and Investigator Site File (ISF) accuracy and inspection readiness
perform quality control, filing, and tracking of essential documents in partnership with CTM, CRAs and TMF Lead as applicable
Data & System Management: Support subject tracking, data entry oversight, and system maintenance in CTMS and eTMF
assist with eCRF UAT testing and clinical sample tracking
Compliance & Audit Readiness: Prepare for and support audits/inspections, support CAPA implementation, and ensure adherence to protocol, GCP, and regulatory requirements
Monitoring & Issue Resolution: Ensure data entry timeliness, speedy query resolution, support CRA’s with protocol deviations follow-ups, and site escalations
support SAE and external data submissions and follow up
Site Relationship Management: Support the CRA in establishing and maintaining strong site relationships. CSA needs to understand site-specific processes, and act as a back-up point of contact for the CRA
or as a primary point of contact when needed

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Clinical Site Associate

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Malaysia , Kuala Lumpur

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field, such as life sciences or healthcare
Previous experience in clinical research or a related field preferred
Strong organizational and communication skills
Ability to work independently and collaboratively in a fast-paced environment
Attention to detail and ability to prioritize tasks effectively

Job Responsibility

Site Support & Oversight: Manage site-level communications, coordinate site training and systems access, and support site readiness activities including pre/post site visit tasks, and follow-up on action items
Document Management: Maintain Trial Master File (TMF) and Investigator Site File (ISF) accuracy and inspection readiness
perform quality control, filing, and tracking of essential documents in partnership with CTM, CRAs and TMF Lead as applicable
Data & System Management: Support subject tracking, data entry oversight, and system maintenance in CTMS and eTMF
assist with eCRF UAT testing and clinical sample tracking
Compliance & Audit Readiness: Prepare for and support audits/inspections, support CAPA implementation, and ensure adherence to protocol, GCP, and regulatory requirements
Monitoring & Issue Resolution: Ensure data entry timeliness, speedy query resolution, support CRA’s with protocol deviations follow-ups, and site escalations
support SAE and external data submissions and follow up

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Programming Manager

Programming Manager role at GSK's Bengaluru site, within the Science and Technol...

Location

India , Bengaluru

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

A bachelor's degree in computer science, statistics, mathematics, life sciences, information technology, or a related field
Demonstrated advanced expertise in CDSIC standards, programming using R, ADaM and SDTM development, study leadership and oversight, technical and non-technical communication, and study management are required
Deep understanding of the end-to-end clinical trial process, statistical programming principles, and stakeholder engagement abilities
Highly proficient in advanced programming languages (e.g., R, SAS, Python) and familiar with data analysis and project management tools
Solid understanding of workflow tools like Jira
Solid understanding of AGILE principles (e.g., flexibility, collaboration, and continuous improvement) and how to effectively apply them within the context of STOM and study activities

Job Responsibility

Develop and manage the study roadmap in alignment with the Clinical Study Action Plan (CSAP) and Project Roadmap
In collaboration with PP, generate study priorities, timelines, backlogs, and sprints within the Agile framework
Proactively identify, monitor, and escalate risks associated with programming activities for their studies and develop understanding of the impact at the project level
Develop advanced expertise in using the tools, processes, and standards and ensure these are implemented within the study
Ensure Key Performance Indicators (KPIs) related to statistical programming and data strategy are met, including contribution to the Trial Master File (TMF)
Lead and contribute to the execution of programming deliverables such as: SDTM and ADaM datasets
tables, listings, and figures (TFLs) related to the Clinical Study Report
annotated case report form (aCRF)
output specifications (i.e. mock shells)
regulatory documentation such as reviewers’ guides, define.xml, and Health Authority responses

Fulltime

Clinical Study Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Warren, NJ or Cambridge, MA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Must have a Bachelor's Degree
Must have a minimum of 2 years industry related work experience
Experience supporting global trials (NA, LAM, EU, APAC, India)
Experience working in TMF, CTMS, Sharepoint
Excels in written and verbal communications
Self-starter, can work independently with minimal oversight, solution-oriented
ICF review experience
General competency: powerpoint/excel skills, meeting minutes

Job Responsibility

Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

NaaS Architect Principal

The NaaS Architect Principal is central to BT International's network transforma...

Location

Spain , Madrid

Salary:

Not provided

Plusnet

Expiration Date

Until further notice

Requirements

Strategic Architecture Leadership – Proven ability to define and communicate network architectural vision, with track record driving large-scale network transformation programs in service provider or cloud environments
Network Architecture Expertise – Deep understanding of service provider networks including SDN, segment routing, MPLS, BGP and overlay technologies, combined with cloud-native networking and container networking patterns
Platform Engineering Mindset – Strong understanding of platform-as-a-product principles, building self-service capabilities and treating internal teams as customers with clear SLAs
API & Integration Architecture – Extensive experience designing API-driven architectures using RESTful, gRPC and event-driven patterns, with knowledge of industry standards including TMF, MEF and CAMARA
Technical Depth – Hands-on background in network engineering with coding capability in at least one language (Python, Go) and participation in technical spike or proof of concept work
Automation & Infrastructure-as-Code – Strong background in network automation, infrastructure-as-code (Terraform, Ansible) and GitOps with Flux/Argo CD
Cloud-Native & Multi-Cloud – Experience with cloud-native patterns including Kubernetes, containers and orchestration, operating across multi-vendor and multi-cloud environments
Observability & Network Operations – Knowledge of observability systems (ELK, Prometheus, Grafana, gNMI), telemetry pipelines, event streaming platforms (Kafka), orchestration platforms (Itential, NetBox) and traffic engineering controllers
Telco Transformation Context – Experience navigating organizational and technical challenges of telco network modernization while maintaining operational continuity
Zero Touch Operations – Knowledge of intent-based networking, automated remediation, workflow-driven operations and compliance management that enable zero-touch networking principles

Job Responsibility

Define and lead the architectural strategy for NaaS platform evolution, establishing target state architectures that balance functional requirements with non-functional requirements including scalability, resilience, security and cost optimization
Work hand in hand with product engineering squads to provide hands-on architectural guidance, working directly with engineers to deliver product excellence as well as technical spikes and proof-of-concepts
Drive API-first architecture across network services, establishing patterns for exposing network capabilities through modern integration approaches including RESTful APIs, gRPC and event-driven patterns, with alignment to industry standards including TMF, MEF and CAMARA
Lead vendor rationalization strategy across network equipment vendors, cloud providers and orchestration platforms, reducing vendor dependencies through strategic build vs buy decisions and phasing out unnecessary third-party systems in favor of composable in-house capabilities
Champion modern architecture patterns including infrastructure-as-code, GitOps, automated provisioning and cloud-native networking that enable continuous delivery and operational excellence
Establish observability frameworks for network services including telemetry pipelines, metrics collection, distributed tracing and logging strategies that enable proactive operations and rapid troubleshooting
Collaborate with platform engineering teams to build Internal Developer Platform capabilities that abstract network complexity and provide self-service access to network functions
Drive architectural governance through design reviews and conformance processes, ensuring solutions align with platform standards while empowering product team autonomy
Provide technical thought leadership on network architecture including SDN underlay, control plane, management plane APIs and telemetry, translating industry trends and technological advances into roadmaps that align with BT International's platform strategy
Mentor architects and engineers, fostering architectural thinking and technical leadership capability across both the architecture and product engineering organizations

Senior Manager BSS Domain Tech Lead

We are seeking a BSS Domain Lead to define, architect, and optimise Business Sup...

Location

India , Pune

Salary:

Not provided

Vodafone

Expiration Date

Until further notice

Requirements

Holder of a bachelor’s degree in engineering, computer science, or a related domain
an MBA or telecom‑specific certifications are beneficial
Brings 10+ years of experience in telecom IT solutions with strong exposure to BSS architecture and product ownership
Experienced in large‑scale transformation or digital modernisation programmes
Skilled in analytical thinking, problem solving, stakeholder engagement, and structured decision‑making
Comfortable working in agile environments with cross‑functional teams and distributed stakeholders

Job Responsibility

Define and design BSS architecture in alignment with business and technology strategies, leveraging TMF APIs, eTOM, and TAM frameworks
Lead solution design across billing, charging, CRM, order management, and revenue assurance domains
Collaborate with cross‑functional stakeholders to translate requirements into scalable and efficient technical solutions
Ensure seamless integration between BSS, OSS, middleware, and external platforms
Provide technical leadership during implementation, ensuring best‑practice compliance and architectural governance
Conduct impact assessments, risk evaluations, and performance optimisation across BSS solutions
Drive digital transformation initiatives to enhance customer experience, optimise operations, and improve service quality
Manage product roadmaps, backlogs, and prioritisation within agile delivery frameworks such as Scrum and SAFe
Oversee business process design and management using ARIS, draw.io, JIRA, Confluence, and DevOps methodologies
Monitor emerging technologies and recommend enhancements to strengthen BSS capabilities

What we offer

Opportunity to work on high‑impact, global digital transformation programmes
Experience collaborating with diverse teams across multiple markets and technologies
Exposure to advanced telecom architectures, BSS‑OSS platforms, and modern integration frameworks
Continuous learning through hands‑on work with agile methodologies and enterprise‑scale tools

Clinical Digital Systems Analyst

Parexel is currently seeking a Clinical Digital Systems Analyst (Technical Admin...

Location

Poland

Salary:

250000.00 - 345000.00 PLN / Year

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s degree, science, healthcare and/or technology preferred
At least 3 years of experience in clinical related technology for the pharmaceutical/biotechnology industry
IT-literate and passionate/experienced towards new technology and digital systems (e.g. Microsoft-based applications, LMS, CTMS, eTMF, clinically focused subscription databases)
Substantial previous clinical trials experience, with emphasis on GxP and compliance
Has a sound working knowledge of clinical operations, clinical processes, medical terminology, global CROs and vendor management
Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies
Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation
Excellent interpersonal, verbal and written communication skills and ability to effectively interface with CROs and software vendor partners
Ability to work independently and take initiative
Ability to handle highly complex projects/task and work effectively in a matrix environment

Job Responsibility

Represents their department and collaborates with Information Services (IS) regarding the implementation and management of digital systems/technology used
Works with the ‘Performance and Training’ function to facilitate the collation, visualization, analysis & storage of relevant metrics to ensure optimal trial performance and aid continuous improvement
Ensures global consistency of approach for digital systems and technologies between clinical trials by increasing awareness of those systems/technologies
Establishes, maintains, reviews and manages the digital systems (e.g. CTMS, TMF and other ‘platform’ systems)
User access lead on CTMS, eTMF, SharePoint and other Clinical Systems
Works closely with IS and the digital system providers, ensuring teams are trained appropriately in the relevant digital systems
Identifies improvement opportunities related to digital systems and assists with developing enhancement plans and roadmaps
Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all CTMS functionality, ensuring best use of subscription databases)
Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization
Collaborates with subject matter experts on development of relevant training materials, QMS documentation, and Validation activities and documentation

What we offer

Open and friendly work environment
Opportunities to develop long-term careers
Opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments
Performance-based bonus plan (for eligible roles)
Annual salary review
Total rewards incentives (for eligible roles)

Fulltime

Order Management Architect

We are seeking an experienced Order Management Architect to define, govern, and ...

Location

India , Pune

Salary:

Not provided

Vodafone

Expiration Date

Until further notice

Requirements

Expert-level knowledge of Java and Spring Boot microservices with proven experience in REST API design
Demonstrated hands-on experience with Camunda BPMN/DMN, including workflow operations, incident handling, and optimisation
Strong proficiency in Drools for high‑throughput decisioning, rule governance, and automated testing
Solid experience developing enterprise‑grade user interfaces using React
In‑depth understanding of order management principles including acceptance, validation, dependency management, sub‑order orchestration, routing, and lifecycle tracking
Bachelor's degree in Computer Science, Computer Engineering, or equivalent practical experience
Experience working with modern cloud technologies and cloud-native architectures

Job Responsibility

Define and evolve the Order Management Platform architecture, including domain models, bounded contexts, integration patterns, and orchestration frameworks
Establish microservice design standards using Java and Spring Boot, alongside API conventions such as OpenAPI and TMF
Develop and maintain non‑functional baselines covering latency, throughput, availability, and error budgets
Lead Camunda‑based workflow architecture and modelling for order acceptance, validation, decomposition, dependency handling, jeopardy management, and orchestration
Govern Drools‑based rules architecture for routing, prioritisation, decomposition, backend selection, testing, and promotion
Guide the creation of secure and responsive React interfaces for operational and self‑service fulfilment use cases
Define harmonised data models for orders, sub‑orders, and order lines across varied backend systems
Ensure TMF‑aligned API definitions to support cross‑channel and partner interoperability
Oversee end‑to‑end management of technical and functional order management processes
Provide architectural direction and design governance across all platform components

What we offer

Opportunity to define and shape a core enterprise platform critical to multi‑country digital operations
Exposure to modern cloud‑native, API‑driven architectures and industry standards
Collaboration with global teams and multi‑functional stakeholders
A role offering continuous learning in workflow automation, rules management, and large‑scale orchestration

TMF Lead

iconplc

Location:
Poland , Warsaw

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 27, 2026

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