Allucent

Research Analyst

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Activities around regulatory affairs, site activation and study-startup.

Clinical Research Associate, Belgium, Netherlands

Program Coordinator

• Manage project communications and stakeholder coordination: Facilitates communication across the team, sponsors, contractors, and functional areas; maintains project email groups and supports strong client relationships.
• Conduct meeting planning and follow-up: Schedules, prepares for, and attends internal/external meetings; creates agendas, documents discussions, distributes minutes, and tracks action items and decisions.
• Project documentation, training, and reporting: Manages the collection, filing, archiving, and transfer of project documents; supports training records and study-specific training logistics; prepares status reports and project metrics.
• Provide financial, proposal, and operational support: Leads proposals, cost estimates, change orders, and budget closeouts; tracks project budgets, supports forecasting and invoicing, and helps drive revenue, billability, margins, and biometrics team targets.

Senior Biometrics Program Coordinator

AI Engineer

• Architect, develop, and deploy scalable AI-driven systems using Python, FastAPI, and Azure OpenAI.
• Build and maintain microservices using Python, FastAPI for AI and data processing workflows.
• Design and optimize Retrieval-Augmented Generation (RAG) pipelines integrating Azure Cognitive Search and Cosmos DB.
• Integrate advanced search functionalities using Azure Cognitive Search and external search APIs (e.g., Perplexity, Bing Search API)
• Utilize MS Visual Studio Code, Git, and Azure DevOps for version control and CI/CD deployment.
• Prepare detailed documentation of APIs, workflows, and AI pipelines for maintainability and scalability.

QA Engineer

• The Quality Assurance Officer II (Quality Officer II) coordinates development and management of Quality Management Systems documents as needed, performs audits as appropriate, co-hosts and may lead customer audits, supports quality issue/deviation/CAPA closures, participates in regulatory inspections, and performs quality control review of regulatory documents as needed of Allucent Quality Department and other quality activities as directed. This position monitors quality activities.
• **In this role your key tasks will include:**
• - Development and management of quality documentation, including but not limited to, SOPs, training, and sponsor documentation as directed
• - Co-host and may lead customer audits
• - Participate in regulatory inspections
• - Perform audits (e.g., process, project, vendor, investigator site), as appropriate
• - Perform quality control review of regulatory documents as needed
• - May lead quality issue/deviation investigation, follow-up/closure, and CAPA closures as directed
• - Provide essential training oversight management, leading maintenance of training curricula and learning management system administration as directed
• - Assist with the development and delivery of training materials as agreed with senior management
• - Actively support staff learning & development within the company
• - Draft and contribute, as Subject Matter Expert (SME) in the field of Quality Officer, activities to the evaluation and harmonization of processes and procedures within the Quality Management System
• - Assure good communication and relationships with (future) clients
• - May contribute and take part in client evaluations, visits and bid defenses
• - May act as primary contact within the quality staff for dedicated areas/assignments
• - Support other quality activities (e.g., RFI and vendor questionnaire, quality metrics and CSV) as directed
• - Contribute to other areas of business and other duties as assigned

Quality Assurance Officer II

Director

• Oversee the project **and be responsible for the overall quality and management of the deliver clinical trial projects and programs. This includes overseeing the budget, reviewing and approving content and costing of proposals, problem solving with project teams, and balancing multiple competing priorities.
• Serve as the key contact for assigned clients** on delivery of scope, customer satisfaction on services and capabilities and the assessment of client needs.
• Lead the project team. **You will demonstrate knowledge of and insight into general business principles and practices, demonstrate a growth mindset, and support the recruitment and interviewing of new employees.

Project Director – Oncology

Software Engineer

• Lead clinical programming activities across assigned studies, ensuring project timelines, budgets, deliverables, and resource needs are effectively managed while proactively identifying and escalating risks or change orders.
• Design, build, validate, and maintain clinical databases, electronic edit checks, data listings, and data visualization tools to support high-quality data collection, review, and regulatory compliance.
• Collaborate cross-functionally with Data Management, Project Management, Biostatistics, and study teams to develop study documentation, clarify technical specifications, and deliver programming solutions that meet project objectives.
• Champion industry standards and quality, applying CDISC conventions (CDASH, SDTM, TAUGs), validation principles, and programming best practices to ensure consistent, compliant, and inspection-ready deliverables.
• Drive innovation and continuous improvement by leading process enhancements, developing global programming standards and libraries, implementing data analytics and visualization tools, and supporting departmental initiatives.

Senior Clinical Programmer

Medical Director

• Identify, develop and implement the business strategy for the Medical Affairs and Pharmacovigilance departments
• Develop and agree upon annual revenues, sales, profit and operational targets for the Medical Affairs and Pharmacovigilance departments
• Evaluate and direct the organization's activities to achieve targets for trading performance, quality, culture and legislative adherence.
• Develop and agree upon operating procedures / business processes
• Preside as needed over (senior) management team meetings
• Maintain and develop organizational culture, values, and reputation
• Report to applicable stakeholders on business strategy planning, results and performance for the Medical affairs and Pharmacovigilance department
• Act as the organization's representative in its dealings with the outside world
• Manage direct reporting staff
• Actively contribute to staff learning & development within the company
• Monitor and assure client satisfaction on existing projects for the Medical Affairs and Pharmacovigilance department with related activities
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business

Chief Medical Officer

General

• Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required
• Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class
• Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance
• Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed
• Performs local literature screening and collection of safety information
• Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required
• Supports local signal detection, if applicable
• Manages locally risk minimization measures, as applicable
• Reports to and maintains regular communication with the EU QPPV
• Supports the review of local PV agreements, if requested
• Performs local PV training to eg. sales force, affiliate personnel, distributors
• Provides monthly activity report on status of local PV system

Local Contact Person, Pharmacovigilance – Freelance, PT

• At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• We are looking for a Clinical Trial Leader (CTL) to join our A-team (office-based*/remote). As a CTL at Allucent, you are providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality.
• ResponsibilitiesAs an expert in Clinical Trial Leadership, you are:
• - **Coordinating and managing CRA activities **across all geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (timeline, budget, quality, productivity) are met.
• - **Liaising closely with the Project Manager (PM) and other department leaders** if /when necessary, on all trial-related issues and service delivery.
• - **Supporting the management team **with training, process improvements, co-monitoring visits, mentoring of staff and / or any other special assignments within Global Clinical Operations.

Clinical Trial Leader

• Coordinate and manage the activities of Clinical Research Associates (CRAs) across all geographic regions
• Maintain close liaison with the Project Manager (PM) and other department leaders on all trial-related and service delivery matters
• Support the leadership team through training, process improvements, co-monitoring visits, staff mentoring and/or other special assignments within Global Clinical Operations

Clinical Trial Leader / Head of Clinical Studies

• Independently manage all aspects of monitoring for assigned clinical trials across study phases, including site initiation, routine monitoring, and close-out visits.
• Ensure compliance with protocols, GCP, ICH, SOPs, and applicable regulatory requirements.
• Build strong site relationships, acting as a primary point of contact and ensuring high-quality data collection.
• Identify and resolve site issues, escalating as needed to maintain trial integrity and patient safety.
• Mentor and support junior CRAs, sharing knowledge and best practices.

Clinical Research Associate II – Sr Clinical Research Associate

• At** Allucent™**, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• As the Sr. Director, CMC, you will:
• - **Lead end-to-end CMC strategy** across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
• - **Drive regulatory excellence** by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
• - **Prepare product development plans** from early development through Phase 4.
• - **Manage and lead direct reports** through development and performance management and by providing training on current and new regulatory requirements.
• - **Perform other scientist related duties**, as needed.

Senior Director, CMC

• **Key Responsibilities:**
• - Design and implement end-to-end data pipelines using Azure Databricks, Azure Data Factory, and ADLS Gen2.
• - Build scalable and performant data models for data lakes (Medallion architecture), data warehouses, and operational systems.
• - Develop ELT/ETL frameworks for ingestion from APIs, relational sources, flat files, and third-party systems (e.g., Dynamics 365, Veeva, EDC).
• - Optimize data transformations, partitioning, and delta lake performance for analytics workloads.
• - Leverage Python and PySpark for data ingestion, cleansing, enrichment, and advanced transformations.
• - Implement CI/CD pipelines for data workflows using Azure DevOps and Git, including automated testing, deployment, and monitoring.
• - Develop and integrate RESTful APIs for cross-system data exchange and automation.