Clinical Study Manager, Utrecht, Utrecht

The company Our client is an innovative biotechnology organisation focused on developing transformative treatments for patients with serious diseases. The organisation operates in a highly regulated clinical research environment and is committed to maintaining high standards of patient safety, data integrity, and clinical trial quality. Role Description We are looking for an experienced Clinical Trial Operations Manager to lead and coordinate clinical trials in a complex, cross-functional environment. In this role, you will oversee trial execution in collaboration with internal Clinical Management Teams (CMTs), Contract Research Organisations (CROs), and other external partners. Responsibilities - Lead the cross-functional, trial-specific Clinical Management Team (CMT), including CROs, to ensure clinical trials are delivered within agreed timelines and budgets and in accordance with quality standards. - Coordinate internal and external stakeholders to support effective collaboration, communication, and progress throughout the clinical trial lifecycle. - Contribute to CRO selection, define scopes of work, and manage ongoing CRO performance and deliverables. - Monitor trial progress, identify potential issues, and escalate risks or concerns appropriately to maintain trial quality and timelines. - Ensure clinical trial activities comply with applicable regulations, internal Standard Operating Procedures (SOPs), and ICH-GCP guidelines. - Participate in audits and inspections, coordinating follow-up activities and ensuring timely responses to findings. - Maintain and update trial budgets, including financial forecasting, accruals, and invoice management. - Proactively assess and manage risks related to clinical trial conduct, with particular attention to patient safety and data integrity. - Oversee trial documentation and support the maintenance of accurate, complete, and inspection-ready clinical trial records. - Drive accountability across the CMT and external partners to ensure milestones, deliverables, and quality expectations are met. Requirements - Bachelor's or Master's degree in a relevant field; a Master's degree is preferred. - At least 5 years of experience in clinical operations. - Significant experience leading and managing clinical trials within the pharmaceutical, biotechnology, or clinical research industry. - Demonstrated experience coordinating clinical trial activities, maintaining trial documentation, and managing CRO relationships. - Experience with clinical trial budget monitoring, financial forecasting, accruals, and invoice management. - Good understanding of clinical trial regulations, ICH-GCP guidelines, and quality requirements. - Experience with risk management, patient safety, data integrity, and audit or inspection readiness. - Strong project management, organisational, and problem-solving skills. - Excellent communication and stakeholder-management skills, with the ability to coordinate cross-functional teams and external partners. - A proactive, structured, and quality-focused approach, with the ability to manage multiple priorities and resolve issues effectively. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company Our client is a leading organisation in the life sciences sector, focused on developing innovative therapies and running high-quality clinical research. The team works in a highly regulated environment and partners closely with internal stakeholders and external vendors to deliver trials efficiently, safely, and in full compliance. Job Description We are looking for a Clinical Trial Manager to take ownership of the operational delivery of clinical trials. This person will lead a cross-functional trial team, manage external partners such as CROs, and ensure trials are delivered on time, within budget, and to the required quality and compliance standards. Responsibilities - Lead the trial-specific cross-functional Clinical Management Team, including oversight of CRO partners. - Drive trial delivery to meet agreed timelines, budget, and quality expectations. - Build strong collaboration with internal and external stakeholders to support smooth trial progress. - Support selection of CROs and contribute to defining scope of work and expectations. - Actively manage CRO performance throughout the trial and ensure clear communication and follow-up. - Ensure issues and risks are identified early and escalated appropriately to protect progress and quality. - Support audits and inspections and help drive timely responses when needed. - Maintain and manage trial budgets, including forecasting, accruals, and invoice coordination. - Lead risk management activities related to patient safety and data integrity. Requirements - Bachelor’s degree in a relevant field (Master’s degree preferred). - At least 5+ years of experience in Clinical Operations. - Proven experience leading and managing clinical trials. - Strong experience working with CROs and coordinating trial activities. - Solid understanding of regulated clinical trial delivery and quality expectations (e.g., ICH-GCP and internal SOPs). - Comfortable working with trial documentation and budget monitoring. - Temporary Full-Time Contract (6 Months) Other Information This is a great opportunity for an experienced clinical operations professional who enjoys owning trial delivery and working closely with a wide range of stakeholders. If you are interested and want to apply, please submit your application via the apply button below and contact me.

The Company An international life sciences organization focused on developing innovative healthcare solutions. The organization operates in a collaborative, global environment and values quality, inclusion, and the contribution of its people. Role description The Talent Acquisition Manager will support recruitment across European operations while collaborating with an international Talent Acquisition team. The role involves partnering with Hiring Managers and HR Business Partners to attract and recruit talent across multiple functions and seniority levels. This position is responsible for managing the full recruitment lifecycle, providing recruitment advice, and delivering a positive candidate and hiring manager experience. It also contributes to improvements in recruitment processes and broader Talent Acquisition initiatives. This is a temporary position for six months, with a hybrid working model combining office attendance and remote working. An extension is not currently anticipated; any continuation will depend on business needs. Responsibilities Manage the full recruitment lifecycle, including intake meetings, job postings, sourcing, screening, interviewing, offers, and recruitment system administration Partner with Hiring Managers and HR Business Partners to understand business needs and develop effective recruitment strategies Conduct role briefings to agree on candidate profiles, recruitment timelines, and hiring expectations Build and maintain diverse talent pipelines for current and future recruitment needs Proactively identify and engage suitable candidates through multiple sourcing channels Support recruitment for permanent and contract positions, working with external recruitment partners where appropriate Deliver a positive candidate experience through clear communication, timely updates, and effective relationship management Ensure recruitment activities comply with internal policies, applicable local employment regulations, and hiring best practices Provide market insights and recruitment trends to support informed hiring decisions Contribute to recruitment process improvements, employer branding activities, and Talent Acquisition projects Collaborate with international recruitment colleagues to share best practices and support changing hiring volumes Requirements Bachelor's degree Minimum of 2 years of experience in Talent Acquisition, Recruitment, or Human Resources with substantial recruitment responsibilities Recruitment experience within biotechnology, pharmaceuticals, life sciences, or healthcare strongly preferred Experience managing full-cycle recruitment across multiple functions and seniority levels Strong stakeholder management skills, with the ability to advise and influence Hiring Managers Excellent communication and interpersonal skills, with the ability to build trusted relationships in an international environment Strong organizational skills and the ability to manage multiple vacancies and competing priorities A proactive, solution-oriented approach and strong problem-solving abilities High standards of professionalism and discretion when handling confidential information Experience using an Applicant Tracking System; familiarity with enterprise HR systems is an advantage Proficiency with Microsoft 365

Company Our client is a well-established manufacturer operating in a fast-paced production environment. The organization is focused on delivering high service levels to customers through efficient planning, continuous improvement, and strong collaboration between Supply Chain, Production, Engineering, and IT. Job Description For our client, we are looking for a Production Planner to take ownership of end-to-end production planning while also acting as the go-to expert for ERP and MRP usage and optimization. This role combines hands-on planning responsibility with longer-term improvement initiatives, supporting the business in improving reliability, efficiency, and data quality across the planning process. Responsibilities - Build, maintain, and continuously improve short-, mid-, and long-term production plans. Align demand, capacity, and material availability to ensure stable delivery performance and service levels. - Identify risks and bottlenecks early and drive corrective actions with relevant stakeholders. - Act as the key user for ERP/MRP topics, ensuring the systems support planning effectively. - Improve and maintain planning parameters and master data (e.g., lead times, safety stocks, order quantities, capacity settings). - Lead or coordinate ERP optimization initiatives, upgrades, and system-related improvement projects. - Train, support, and guide colleagues across departments to strengthen process adoption and ways of working. - Translate complex planning challenges into practical solutions and support change implementation. - Contribute to performance reporting and KPI insights to support decision-making and prioritization. - Work closely with cross-functional teams (Supply Chain, Operations, Production, Engineering, Quality/HSE, and IT) to drive planning excellence. Requirements - Higher professional education level (HBO or similar). - Strong experience in production planning / supply chain planning / operations planning. - Demonstrable experience with ERP implementation or ERP optimization projects. - Solid understanding of MRP concepts and production processes. - Experience with ERP systems (e.g., SAP, Microsoft Dynamics, Oracle, CSB, or similar). - Strong analytical skills and confidence working with data to improve processes. - Comfortable driving improvements and supporting change in a production environment. - Good command of both Dutch and English. - Certifications such as Lean Green Belt, APICS CPIM, or similar are a plus. Other Information This is an on-site role in a production environment, working closely with operational teams and stakeholders to improve planning performance and system effectiveness. If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company: A leading organization dedicated to manufacturing and production, committed to operational excellence and continuous improvement. The company values proactive professionals who thrive in a dynamic environment and are focused on optimizing supply chain processes. Job Description: We are seeking a skilled Senior Supply Chain Planner to join our client's team. In this role, you will be responsible for developing and maintaining reliable production schedules, ensuring optimal alignment between demand, capacity, and materials. You will play a key role in enhancing supply chain efficiency by leveraging your expertise in ERP systems and production planning to support the company's growth and operational targets. Responsibilities: - Develop and oversee short-, medium-, and long-term production schedules, balancing capacity, material availability, and customer demand. - Monitor and improve delivery reliability, service levels, and production efficiency. - Identify potential risks and bottlenecks, implementing corrective actions proactively. - Act as the main point of contact and key user for ERP and MRP systems, continuously optimizing these platforms for planning accuracy. - Lead improvements in ERP functionality, including data quality, master data, and planning parameters. - Manage safety stock levels, order quantities, lead times, and capacity settings. - Collaborate with cross-departmental teams to execute technical projects, system upgrades, and compliance initiatives. - Analyze supply chain and production data to identify performance gaps and drive continuous improvements. - Implement best practices in Sales & Operations Planning (S&OP), inventory management, and capacity planning. - Support operational excellence and lean initiatives by leading process improvements. - Prepare reports and KPIs to support management decision-making. Requirements: - Higher professional education (HBO level) in a relevant field. - At least 5 years of experience in production, supply chain, or operations planning. - Strong knowledge of ERP systems such as SAP, Microsoft Dynamics, Oracle, or similar platforms. - Experience with MRP systems and production processes. - Demonstrable experience with ERP implementations or system optimizations. - Strong analytical skills and data-driven mindset. - Knowledge of process improvement and change management. - Proactive, results-oriented approach. - Fluency in Dutch and English. - Certifications such as Lean Green Belt or APICS CPIM are advantageous. Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company A leading organization dedicated to advancing innovative medical treatments, with a focus on improving patient outcomes through cutting-edge therapies. The company operates in a dynamic, multicultural environment committed to saving lives by finding cures for serious illnesses. Job Description We are seeking a highly organized and proactive Supply Chain Coordinator to join our European and Middle Eastern Cell Order Management team. In this role, you will oversee the entire process of cell orders — from receipt of patient cells to final product delivery — ensuring timely and high-quality service. The position offers a fantastic opportunity for career growth within a mission-driven organization committed to making a difference in cancer treatment. Responsibilities -Collaborate closely with internal teams and external partners to coordinate the end-to-end order process for designated European countries. -Monitor daily operations and identify any process bottlenecks, resolving issues promptly to maintain smooth delivery flow. -Build and maintain strong relationships with local commercial teams to ensure seamless communication and service delivery. -Provide proactive updates on order status and resolve any supply chain queries or potential disruptions. -Lead daily meetings with stakeholders to discuss priorities, resolve issues, and ensure efficient workflow. -Contribute to continuous improvement initiatives aimed at optimizing the overall supply chain. -Manage courier shipments and execute order transactions using Oracle EBS systems. -Oversee the order scheduling and tracking system, ensuring up-to-date and accurate information. -Investigate and address deviations or product complaints related to cell order management. -Standardize handling of emergencies and deviations through a documented playbook to ensure consistent, efficient responses. Requirements -A master’s degree in business or engineering, with 2+ years of supply chain or operations experience, or -a bachelor’s degree with 4+ years’ relevant experience. -Proven experience in customer service and supply chain functions. -Familiarity with enterprise systems such as Oracle EBS or SAP. -Previous supply chain experience within the pharmaceutical industry, preferably in oncology, -hematology, or immunotherapy. -Knowledge of GDP and GMP regulations and experience executing SOPs and work instructions. -Excellent communication skills in English, both written and verbal, with the ability to interact confidently at all management levels. -Strong organizational skills with the ability to prioritize and manage multiple tasks efficiently. -Effective problem-solving skills with close attention to detail. -Patient-centric mindset with an understanding of the complexities involved in each individual order. -Openness to learning and continuous process improvement. -Ability to work effectively across diverse cultures in complex, global matrix environments. -Outgoing, collaborative personality with a talent for building consensus among diverse teams. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.  

The Company A leading global biotechnology company focused on developing innovative cell therapies to treat cancer and improve patients’ lives. The organization operates in a collaborative, multicultural environment, with a strong focus on quality, patient care, and continuous improvement. Role Description As a Supply Chain Specialist, you are responsible for managing the end-to-end cell order process, from patient cell collection through final product delivery across Europe and the Middle East. You coordinate with internal and external stakeholders, resolve operational challenges, manage shipments, and ensure timely, high-quality delivery in compliance with pharmaceutical quality standards. Responsibilities Coordinate end-to-end cell orders and ensure timely delivery across assigned European markets. Collaborate with commercial teams and internal and external stakeholders to manage order status, resolve queries, and prevent supply disruptions. Monitor daily operations, identify bottlenecks, resolve issues, and escalate risks when necessary. Lead operational meetings to review priorities, address challenges, and ensure smooth order execution. Manage courier shipments and process order transactions using Oracle EBS and Kite Konnect. Maintain accurate order scheduling and tracking systems. Investigate and manage deviations and product complaints related to cell order management. Drive continuous improvement initiatives and maintain standardized procedures for handling emergencies and operational deviations. Requirements Master’s degree in Business or Engineering with at least 2 years of operations or supply chain experience, or a bachelor’s degree with at least 4 years of relevant experience. Experience in customer service and supply chain operations. Experience with ERP systems such as Oracle EBS or SAP in a production environment. Pharmaceutical supply chain experience, preferably in oncology, hematology, or immunotherapy. Knowledge of GDP, GMP, SOPs, and work instructions. Strong communication skills in English, both written and verbal. Excellent organizational, problem-solving, and multitasking skills with strong attention to detail. Patient-focused mindset with the ability to manage time-critical and complex orders. Understanding of end-to-end business processes, Lean, and operational excellence is an advantage. Ability to collaborate effectively in a multicultural, cross-functional environment and adapt to changing priorities. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.  

The Company A leading food manufacturer specializing in frozen snacks and appetizers for customers across various markets. The organization focuses on delivering high-quality products while maintaining strict food safety standards, operational efficiency, and continuous improvement. It offers a dynamic production environment with opportunities for professional growth and collaboration across teams. Role Description As a Senior Production Planner, you are responsible for aligning production plans with customer demand, capacity, and material availability. You optimize ERP and MRP systems, improve planning processes, and drive operational efficiency through data analysis and continuous improvement. Working closely with Supply Chain, Production, Operations, and IT, you ensure reliable deliveries and optimal inventory levels. Responsibilities - Develop and monitor short-, medium-, and long-term production plans, ensuring alignment between demand, capacity, and material availability. - Optimize delivery performance, production efficiency, and inventory levels while identifying and resolving planning bottlenecks. - Act as the key user for ERP and MRP systems, improving system functionality, planning parameters, and master data accuracy. - Support ERP implementations, upgrades, and optimization projects, including training and guiding end users. - Analyze production and supply chain performance, develop KPI reports, and identify opportunities for process improvement. - Lead initiatives focused on Lean, Operational Excellence, capacity planning, and inventory management. - Collaborate with Supply Chain, Production, Operations, and IT to implement process improvements and support change management. Requirements - HBO-level education or equivalent. - Minimum of 5 years of experience in production planning, supply chain planning, or operations planning. - Demonstrable experience with ERP implementations, system optimization, or improvement projects. - Strong knowledge of MRP principles, production processes, and planning parameters. - Experience with ERP systems such as CSB, SAP, Microsoft Dynamics, Oracle, or similar platforms. - Strong analytical skills, data-driven decision-making capabilities, and experience with KPI reporting. - Experience in continuous improvement, process optimization, and change management. - Proactive, results-oriented, and capable of working effectively with cross-functional teams. - Good command of both Dutch and English. Other Information If you are interested and want to apply, please submit your application via the apply button below and contact me.

Job Description: We are seeking a dedicated Facilities Maintenance Specialist with strong expertise in clean utilities systems to ensure the reliable and compliant operation of pharmaceutical water systems (WFI and WDI). The role involves supporting maintenance and engineering efforts related to GMP-compliant utilities critical to the production process. Responsibilities: •    Support the Business System Owner (BSO) for GMP water systems, including WFI and WDI, ensuring optimal system availability and performance. •    Collaborate with maintenance and engineering teams on long-term investment plans and CAPEX projects. •    Present investment proposals during budget planning cycles, incorporating insights from the BSO. •    Assist in managing change processes during design, commissioning, and qualification phases, evaluating impacts and ensuring compliance with GMP standards. •    Support installation and upgrade activities, ensuring reliability, quality, and cost-effectiveness. •    Participate in engineering projects, including system handovers, to guarantee operational readiness and GMP compliance for BMS and EMS systems. •    Ensure adherence to all regulatory and Johnson & Johnson policies regarding manufacturing asset management, EHS, and GMP. Requirements: •    HBO level education or equivalent, preferably with a technical background. •    Minimum of 2 years' experience in a regulated pharmaceutical or GMP environment. •    Proven expertise with GMP systems, WDI/WFI utilities, and control strategies (BMS). •    Skilled in reading and editing P&ID diagrams. •    Strong problem-solving skills and meticulous attention to detail. •    Good communication skills in English. •    Knowledge of SAP PM or similar systems is advantageous. Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.

Company Our client is the world’s largest and most broadly based healthcare company. Their aim is to improve access to a healthier lifestyle for everyone thanks to their research in different health areas including personal care products, MedTech and pharmaceutical products.    Job Description As a Maintenance Engineer for Clean Utilities Systems you will join a fast-paced, regulated environment focused on maintaining and optimizing clean utility systems for pharmaceutical production. This role involves supporting the water systems critical to manufacturing processes, ensuring system reliability, GMP compliance, and operational excellence.   Responsibilities Support the Business System Owner (BSO) for clean water systems (WFI/WDI), ensuring optimal availability and performance. Manage the GMP water, BMS, and EMS asset portfolio to uphold quality standards and operational reliability. Collaborate with maintenance and engineering teams to develop long-term investment plans, including CAPEX proposals. Present investment plans during budget cycles, incorporating input from relevant stakeholders. Participate in change management processes during design, commissioning, and qualification phases, assessing impacts and feasibility. Support installation activities to meet reliability and quality standards, and ensure successful project handovers. Assist with engineering projects and contribute to maintaining GMP compliance throughout system upgrades and modifications. Ensure all activities meet regulatory standards and internal policies regarding GMP, EHS, and asset management.   Requirements Higher professional education with a technical background preferred. At least 2 years of experience in a regulated (GMP/pharmaceutical) environment. Familiarity with GMP systems and asset management, particularly within pharma. Hands-on experience with WDI/WFI systems and their control strategies (BMS). Ability to read and modify P&IDs accurately. Strong problem-solving skills and keen attention to detail. Excellent communication skills in English. Knowledge of SAP PM or similar systems is a plus.   Other Information If you are interested and want to apply, please submit your application and contact me.