Join the Grifols Talent Community - Quality Location: Dublin, IE Contract Type: Regular Full-Time Area: Quality Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Join the Grifols Talent Community – Quality Professionals Wanted! Are you passionate about quality, compliance, and making a difference in healthcare manufacturing? At Grifols , we’re building a network of talented individuals who are ready to shape the future of biopharmaceuticals. If you have experience in Quality Assurance , we want to connect with you! We’re especially interested in professionals with expertise in: QA Manufacturing Analyst QA Batch Release QA Compliance QA Validation QA Shop Floor Why Join Our Talent Community? Be the first to hear about new QA opportunities. Stay connected with our Talent Acquisition team. Get insights into life at Grifols and our mission to improve lives. Our Benefits Include: Highly competitive salary Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match Private Medical Insurance for the employee Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Wellness activities - Social activities eg. Padel, Summer Events We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you. #J-18808-Ljbffr
Warehousing & Inventory Control Operator Location: Dublin, IE Contract Type: Regular Full-Time Area: Manufacturing Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. POSITION SUMMARY The purpose of this role is to support the manufacturing / Packaging operation by receiving Raw materials, Frozen Human Plasma & Products from vendors. Preparing materials to supply the manufacturing / Packaging operations. Those activities are to be conducted in compliance with GMP/GDP regulations. While adhering to all site‑specific standard operation procedures & Policies. KEY RESPONSIBILITIES Unload Inspect materials / products received from Vendors. This will include ambient, chilled & -30⁰c trucks. Perform all relevant transactions in SAP & SGP Physically locate material & products into the warehouse’s Ambient, Chilled & -30⁰c using manual handling equipment & RF Terminals Prepare all packaging components/products for the Manufacturing using SAP & in accordance with BOM Prepare Frozen Plasma shipments for outbound delivery Load frozen trucks with Plasma Working in -30⁰c for periods of time Basic error handling on automatic warehouse Ensure all materials are stored and handled in a compliant manner to effectively protect against damage, loss and/or shrinkage Conduct and/or assist in physical inventory counts Maintain housekeeping of warehouse and working areas at all times to ensure compliance to site policies and GMP/GDP Conduct daily / pre shift inspection on material handling equipment Participate in / prepare for internal & external audits. Participate in training as required both onsite & off‑site Working in different departments when required Any other duties assigned by Supervisor / Manager PERSON SPECIFICATION To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required Minimum of 1-3 years of related experience in a pharmaceutical, GMP/GDP, or EU/FDA regulatedEnvironment is required. Current forklift license (Reach, counterbalance, PPT & VNA) with at least 2 years’ experience. Hands‑on experience with SAP or ERP systems preferred Must be proactive, results oriented, and have strong attention to detail. Self‑starter with strong work ethic and the ability to exercise good judgment Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines. Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment. Strong organizational, analytical, and problem‑solving skills with the ability to make structured decisions on a routine basis Demonstrated ability to inspire high performance in others and align team members around shared goals. Excellent verbal and written communication skills in the English language Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Must be flexible with working hours / shifts to accommodate the 24‑hour, 7‑day plant operation. PHYSICAL REQUIREMENTS Ability to lift /move up to 50 pounds. Ability to operate material handling equipment such as pallet jacks and forklifts. Manual dexterity to perform all job functions. Exposure to -30°C ,Ambient, chilled temperatures Note: Due to the nature of the business additional duties may be assigned from time to time. OUR BENEFITS INCLUDE Highly competitive salary Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match Private Medical Insurance for the employee (Irish Life) Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Wellness activities- Social activities eg. Padel, Summer Events We understand that self‑doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you #J-18808-Ljbffr
A global healthcare company is seeking a Quality Compliance Supervisor in Dublin to oversee quality compliance in Albumin Manufacturing. The candidate should have a minimum of 5 years in the pharmaceutical quality field, with a focus on EU GMP regulations. The role requires strong leadership, comprehensive compliance oversight, and technical expertise in sterile manufacturing. Competitive salary and career development opportunities are offered. #J-18808-Ljbffr
Clinical Study Manager - 15 Month Contract Location: Dublin, IE Contract Type: Temporary Full-Time Area: Clinical Trials Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position Summary Contributes to clinical feasibility assessment and strategic planning of clinical trials / studies assigned. Executes on assigned clinical trials / studies in one or more assigned therapeutic area(s). Provides guidance and oversight to internal and external project team members for the successful management of clinical operation activities in accordance with International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols, along with the Program Leader's supervision. This is a maternity cover for 15 months. What you will be doing: General: Contributes to the oversight of integrity of clinical data, obtained from conducted clinical trials, to ensure data meets GCP standards, along with the Program Leader's supervision. Project Management Office (PMO)/pCTSR: Provides support in the preparation of clinical status updates to the Project Management Office (PMO) and to the Upper Management. Clinical Development Strategy/Input: Assists PL in assessing best strategic path forward for a clinical trial / study and contributes to clinical strategy recommendations. Management/Training Team: Manages direct reports through performance evaluations and addressing professional development. Participates and contributes to internal and external training for clinical trials (e.g. kick‑off meeting, Investigator meeting). Ensures appropriate training is conducted for clinical research organization (CRO) staff, vendors, investigators, and study site staff on study requirements and internal SOPs (if applicable). Assist in the identification of study team protocol‑specific training requirements and creates a trial‑specific training plan for the study team. Contributes to the Request for Proposal (RFP) process and participates in vendor selection. Oversees third party vendors performance (e.g., CROs, central laboratories) including on‑time study completion, budget adherence, and quality deliverables along with the senior management. In particular it may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and the oversight of the Trial Master File (TMF) status. Assists in evaluation of vendor performance to ensure early mitigation/resolution of potential issues and serves in key role to develop/implement corrective action plans as appropriate. Performs Sponsor Site Visits at selected sites to oversee the site and the monitoring performances, to increase the communication with the site and awareness of protocol burdens. Documentation of the Sponsor Visits and follow‑up of appropriate corrective and preventive actions. Leads meetings with CROs, vendors, and multi‑functional teams on a day‑to‑day basis to ensure quality, on budget and timeliness of deliverables. Reviews site and vendor invoices to ensure that project expenses are in accordance with work conducted. Reviews escalated issues from study clinical research associates (CRAs) to ensure adequate mitigation plans are implemented (e.g., investigational site monitoring and site audit report findings). Monitoring: Oversees in‑house and vendor monitoring activities including selection of sites, identification of Protocol Deviations and implementation of Corrective and Preventive Actions (CAPAs). Drafts, reviews and approves relevant documents including (but not limited to) informed consent, site worksheets, pharmacy manual, central laboratory manual and clinical monitoring plan along with the Program Leader's supervision. Clinical Trial Design/Performance: Oversees study centres to ensure timely execution of the clinical studies generating quality data. Offers his/her clinical input/review to clinical documents (e.g., protocols, investigator brochures, pharmacy manual, clinical study reports). Provides clinical input in the development of case report forms, data management plan, and data listings review. Collaborates with Biometry to ensure timely data transfers for data cleaning, review and analysis. Contributes to the review of protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis, along with the Program Leader. Contributes to the resolution of escalated study conduct issues from study centres, regulatory authorities and institutional review boards (IRBs)/independent ethics committees (IECs). Tracks and assists in the development of study specific timelines, including management and mitigation of deliverables. Clinical Supply Chain: Requests, distributes and updates insurance certificates for clinical studies. Partners with Manager of Clinical Supply Chain to ensure timely manufacturing, packaging, labelling and shipping of supplies are created according to regulatory/country specifications in required timeline, along with the Program Leader's supervision. Monitors adherence to the regulatory/essential document collection process and release of clinical supplies. Provides support in clinical product technical complaints and product recall as necessary. Safety: Maintains awareness of SAEs that are reported and ensures SAE/SUSAR reporting to IRB/IEC and Principal Investigators, when applicable. Trial Master File (TMF): Provides assistance in the management of the TMF process, including ongoing maintenance, accurate filing and administration of QC plan. Ensures responses to site audits are adequately managed by designated clinical staff. Audits/Inspections/Quality Assurance (QA) Contributes responses to vendor/site audits, along with the Program Leader's supervision. Prepares responses to internal audits, along with the Program Leader's supervision. Provides support to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary. Assists in the preparation of internal inspections, attends internal inspections, and contributes to responses to internal inspections, along with the Program Leader's supervision. Supervises quality of the clinical trial and ensures implementation of CAPAs to quality deviations and misconducts, along with the Program Leader's supervision. Who you will be: Qualifications Advanced verbal, written and interpersonal skills that enable cross‑functional issue resolution. Advanced strategic thinking abilities for proactive planning and decisive decision making. Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs. Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings. Advanced ability to train and mentor CRAs. Typically requires 7-8 years of experience in clinical research, including 3 years in a study management/leadership role. Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross‑functional personnel. Bachelor's degree in relevant discipline. Desirable 8+ years of experience in clinical research, including 3 to 5 years in a study management/leadership role. What we offer: Highly competitive salary Group pension scheme - Contribution rates up to 7% Private Medical Insurance for the employee Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Wellness activities - Social activities eg. Golf, Padel, Summer Events We understand that self‑doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you. Location: EMEA : Ireland : Dublin : Grange Castle (Dublin) #J-18808-Ljbffr
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. POSITION SUMMARY: The Quality Compliance Supervisor will focus on the quality compliance aspects of Albumin Manufacturing, both purification/formulation and aseptically filled product, ensuring that deviations from defined procedures are appropriately handled within a GxP manner, providing assurance of product quality and patient safety. Specifically, the supervisor will be responsible for the team’s scheduling in support of day‑to‑day manufacturing operations, product release, and general business requirements. Additionally, have responsibility of the team’s structure and professional development with coaching, mentoring, and acting as a subject expert in the compliance field to support. The QA Compliance function will be a key stakeholder of all core manufacturing departments, including the wider QA network, manufacturing, validation, QC, and supporting functions. Understanding of industry compliance guidances, notably EU GMP Annex 1 ‘Sterile Manufacturing’, with knowledge of the ICH Q‑series, PDA, ISO, and the FDA Aseptic Guide, will be essential to be successful in this role. What will you be doing? General: Ensure the quality of the work is maintained and inspection‑ready in accordance with internal and external cGxP requirements and expectation. Ensure adherence to GMP, EU Annex 1, FDA, and other applicable regulatory guidelines. Support the cross‑function readiness for batch certification, ensuring all documentation related to the team is finalised within a timely manner. Ensure the team is in compliance with all Training and Health & Safety requirements, in accordance with company policy. Provide the team’s performance status with regular interaction with the wider site departments, as defined via tier/triage‑structures. Establish inter‑team and cross‑team KPIs to ensure performance is measurable for the function’s goals and objectives, aligned with the company’s strategic objectives. Support the team’s organisational structuring and provide general direction to ensure the team is successful in handling day‑to‑day operations, in alignment with the departmental directives. Ensure the team is adequately trained to cover the full scope of team responsibilities, and develop training (internal and external), where appliable, to ensure quality and technical competencies. Be the QA Compliance ‘voice’ / point‑of‑contact for the team to ensure appropriate distribution of communication (given & received), focused on compliance‑related subjects. Support resource management (capacity model & hiring process) for the Compliance function to aid departmental objectives and business requirements. Deputise for the other core QA functions and/or QA Manager, as required. Leadership and Managerial: Provide operational leadership to navigate the QA Compliance team, including coaching, mentoring, performance management, professional development, and objective setting. Manage the team’s routine activities, ensuring they are scheduled, performed, and completed within agreed timeframes and in accordance with procedures and regulations. Activities are inclusive of: Deviation, investigation, and CAPA lifecycle management, including impact analysis, data integrity, and overall quality robustness and effectiveness. Authoring, reviewing, and approving compliance‑related documentation, inclusive of Risk Assessments, SOPs, Training, and Records, as required. KPI monitoring, specifically focused on Deviations, CAPAs, and Training. Periodic GEMBA and walk‑through audits of the manufacturing facility, inclusive of manufacturing areas and quality control laboratories. Internal inspection of QA, QC, Validation, and Manufacturing. Foster a strong stakeholder collaboration with other core QA and MFG functions to ensure quality compliance standards are adhered to. Foster a LEAN attitude to create a pro‑active continuous improvement culture within the team and support the facilitation of ‘Quality Mindset’ throughout the facility. Provide feedback to the team to facilitate professional development and foster an ‘open‑door’ culture. Maintain organised physical and electronic GxP systems to support fast retrieval of information for possible inspection (archiving). Any other duties as required, following consultation with the post holder. Technical: Provide technical expertise, specifically focused on regulations and guidances for sterile manufacture under terminally filtered (aseptic processing) conditions, presented in the form of coaching, mentoring, and presentations for stakeholder understanding. Participate in risk assessments or strategic decision meetings and act as a QA Compliance SME to ensure either new or modified processes are appropriately documented and implemented under GMP conditions for aseptic manufacture. Who you will be? Working experience within a Sterile Pharmaceutical GMP‑regulated industry with a Quality function. Minimum 5 years’ experience in a pharmaceutical quality environment under EU GMP regulation. Working experience with QMS processes, both paper‑based and electronic systems (e.g., Veeva Vault, Trackwise, etc.). Working experience with Deviations, Investigations, and CAPAs of all classifications (Minor, Major, Critical). Working experience of people management (stakeholder or direct). Demonstrate a ‘problem‑solving’ mindset and working ethic/culture to effectively lead the team. Demonstrate project management skillsets for effective handling of multiple high‑priority tasks. Sound understanding of EU GMP aseptic manufacture, notably Annex 1 ‘Sterile Manufacture’. Understanding of ICH Q9 and Q10 Quality Risk Management. Understanding and experience with an EU regulatory body with ‘hands‑on’ inspection experience. Excellent verbal and written communication in English. Proficiency in Microsoft software. Understanding of Albumin manufacture Purification and Aseptic Filling in a bag presentation. Understanding and working experience of cleanroom classifications (Grade A, B, C, & D) and associated controls in‑situ, utilizing RABS technology. Exposure to systems such as SAP, KNEAT, and LIMS. Working experience of people management of ≥2 persons. Verbal and written communication in Spanish and/or Catalan. Demonstrate a ‘problem‑solving’ mindset and working ethic/culture to effectively lead the team. Bachelor or Master’s degree in Pharmaceutical Sciences or Administration. Our Benefits Include: Highly competitive salary Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match Private Medical Insurance for the employee (Irish Life) Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Wellness activities- Social activities eg. Padel, Summer Events We understand that self‑doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you. Location: EMEA : Ireland : Dublin || EMEA : Ireland : Home Office:Grange Castle (Dublin) #J-18808-Ljbffr
A global healthcare company is seeking a Warehousing & Inventory Control Operator to support manufacturing operations. The role includes receiving and preparing raw materials, ensuring compliance with GMP regulations, and maintaining warehouse organization. The ideal candidate has experience in a regulated environment and possesses relevant licenses for material handling equipment. Competitive benefits and career development opportunities are provided. #J-18808-Ljbffr
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. POSITION SUMMARY A Quality Control (QC) Microbiologist is required for the purification and aseptic manufacturing plant at Grifols Worldwide Operations (GWWO), reporting to the QC Microbiology Manager. What will you be doing? Purified Water, Water for injection and Clean steam microbiological bioburden (TVC) and Endotoxin (LAL) analysis. Also analytical testing as required Carry out environmental monitoring including Viable/non‑viable particles monitoring in manufacturing facilities as required Carry out in‑process and finished product microbiology analysis including Total Viable Count (TVC), microbial ID, sterility and Endotoxin testing as required Ensure laboratory processes, equipment and services are installed, qualified and maintained appropriately Participate in the verification, validation and technical transfer of microbiological and analytical testing procedures. Ensure that all cGMP, company specifications and procedures are followed Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required Participate in and be responsible for QC related CAPA’s. Adhere to QC documentation system and prepare and review document change requests as required Develop, improve and implement QC procedures, processes and systems Support projects and continuous improvement initiatives within the Quality department and other functional areas Participate in international project teams relating to QC and wider quality activities and travel may be required Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy and safe at all times Prepare for and support regulatory and internal inspections/audits Provide hands‑on guidance and training when needed Ensure work area is maintained in a state of compliance and audit readiness. Flexibility and willingness to carry out shift work when required Who are we looking for? Knowledge of and demonstrated proficiency in a wide array of current microbiological techniques. Knowledge of and proficiency in the use of analytical instruments. Experience with investigating and determining root cause of Out of Specification and Out of Trends. Excellent verbal and written communication. Must be able to read, write, and speak English. Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. Strong organizational, analytical and problem‑solving skills. Must be able to work a rotating shift pattern, including day and night shifts. Knowledge of sterility failure investigation is desirable. Experience with SAP is desirable. Experience in method transfer and verification/validation is desirable. Knowledge of analytical techniques for biologics or protein‑based therapeutics is desirable. Our Benefits Include Highly competitive salary Group pension scheme – contribution rates are (1.5% / 3% / 5% / 7%) and company will match Private Medical Insurance for the employee (Irish Life) Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Wellness activities – social activities eg. Padel, Summer Events We understand that self‑doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you. #J-18808-Ljbffr
A global healthcare company is seeking a QC Microbiology Manager in Dublin. The role involves managing QC microbiology activities, ensuring compliance, and leading a team. Candidates should have a bachelor’s degree and a minimum of 5 years of QC microbiology experience. Excellent communication and project management skills are essential. The position offers competitive benefits including a salary, pension scheme, and career development opportunities. #J-18808-Ljbffr
A global healthcare leader is seeking a Quality Control Microbiologist for its operations in Dublin. The role entails conducting microbiological analysis and ensuring compliance with regulatory standards. The ideal candidate has strong analytical skills, excellent communication abilities, and the flexibility to work rotating shifts. This position offers a competitive salary and opportunities for career development in a growing environment. #J-18808-Ljbffr
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. POSITION SUMMARY Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the market authorization. Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies) in accordance with International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, applicable regulatory requirements, company standard operating procedures (SOPs), and study protocols. KEY RESPONSIBILITIES Oversees integrity of clinical data to ensure data meets GCP standards. Maintains good knowledge of the literature for the indication being studied and reviews and summarizes all published literature for the therapeutic area of interest. Participates in cross functional project teams and presents program information to internal and external audiences. Investigator Sponsored Research Proposals : Provides clinical review/input to Investigator Sponsored Research proposals. Clinical Development Strategy/Input : Assesses best strategic path forward for a clinical program and drives clinical strategy recommendations including timelines and cost to key stakeholders. Orchestrates expert meetings to elucidate the best clinical path forward for a clinical program. Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies). Escalates significant issues on program(s) and study(ies) to senior management in a timely manner. Project Management Office /pCTSR : Drafts clinical components from decision to start a clinical development and up to the market authorization (DP1-DP5) gates, liaise cross-functionally to provide clinical input on all development stages and Target Product Profile, as necessary. Provides clinical status updates to the Project Management Office (PMO) and to the Upper Management. Team Management/Trainings : Manages direct reports through performance evaluations and addressing professional development. Ensures compliance of each Clinical Development trial team with the trial-specific training requirements. Participates and contributes to internal and external training for clinical program (e.g. Kick-off meeting, Investigator's meeting). Vendor Management : Manages clinical timelines, budgets, and resources against the approved clinical development plan (CDP) in collaboration with contract manager. Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection) and contributes to the vendor selection. Supports the Program Manager in overseeing third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables. In particular it may include the review of monitoring reports, approval of clinical plans, regular review of protocol deviations and activities related to the oversight of the trial master file (TMF) status, completed together with other clinical operations team members. Contributes to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager. Performs Sponsor Site Visits at selected sites to oversee the site and the monitoring performances, to increase the communication with the site and awareness of protocol burdens. Documentation of the Sponsor Visits and follow‑up of appropriate corrective and preventive actions. Clinical Trial Design/Performance : Provides clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities (e.g. Investigational New Drug (IND) application, Clinical Trial Application (CTA), Biologics License Application (BLA), Marketing Authorisation Application (MAA)). Drafts or provides review/input for publications from clinical study data and white paper literature reviews on new products or safety questions. Participates in regulatory authority meetings. Partners with Biometry to develop the case report form, data management plan and statistical management plan. Reviews protocol deviations and data listings to ensure integrity of data and identify trends on ongoing basis. Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis. Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees. Audits/Inspections/Quality Assurance (QA) : Oversees responses to vendor/site audits, as necessary. Oversees responses to internal audits. Contributes to processes improvement. Contributes to preparation of site inspections, attends site inspections, and supports responses to site inspections, as necessary. Manages preparation of internal inspections, attends internal inspections, and manages responses to internal inspections. Supervises quality of the clinical trial and ensures implementation of Corrective and Preventive Actions to quality deviations and misconducts. PERSON SPECIFICATION 10+ years of experience in clinical research, including 2 to 5 years in a study management/leadership role. Advanced verbal, written and interpersonal skills that enable cross‑functional issue resolution. Advanced strategic thinking abilities for proactive planning and decisive decision making. Advanced ability to set and meet deadlines, multitask, and prioritize based on program and/or study needs. Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings. Strong leadership and clinical trial/project management experience in managing study teams, vendors, and other cross‑functional personnel. Bachelor's degree in relevant discipline. Typically requires a minimum of 10 years of clinical research experience with at least 6 years clinical trials management / leadership role, including clinical document production, trial execution and involvement in clinical trial feasibility and strategy. Master’s degree or higher-level degree in relevant discipline. (2‑years’ experience equivalence for a MD and 4‑years’ experience for a master’s degree). Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross‑functional personnel. Our Benefits Include Highly competitive salary Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match Private Medical Insurance for the employee (Irish Life) Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Wellness activities- Social activities eg. Padel, Summer Events We understand that self‑doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you. #J-18808-Ljbffr
