[Apply in 3 Minutes] Clinical Research Program Manager

21 hours ago


Galway, Ireland Life Science Recruitment Ltd Full time

Clinical Research Program Manager Our client, a medical device organisation, are currently recruiting for a Clinical Research Program Manager to join their team on a permanent basis. This organisation is afast growing and dynamic with an extensive research, development and clinical program planned. As Clinical Research Program Manager you be responsible for leading and be part of project teams involved in all clinical programs, including first in human, pilot, pivotal and post-launch studies. You will be required to manage multiple operational studies, provide oversight throughout the development, implementation and conduct of clinical studies globally, develop study plans and project deliverables and will be responsible for other non-trial related activities relating to clinical processes and procedures. Responsibilities Conduct training, direct, develop, evaluate clinical research, which will include the writing of SOPs in accordance with GCP/ICH guidelines Coordinate and supervise clinical research support team, provides project-specific training when applicable Provide training to CRO partner resources such as insourcing CRAs, internal team members including fixed term contractors Review site monitoring visits/reports Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures Ensure that all Study Personnel are current with all required certifications/documents (i.e., Citi certifications) Track and report the progress of studies, including patient enrollment, accounts receivable, monitoring visits, and AE/deviation reporting Ensure supplies and equipment are available for studies as necessary Identify and provide solutions to clinical trial issues and/or risks Submit IRB applications and stay up to date with protocol amendments and informs/trains staff when modifications are required. Work closely with sponsors, CROs and CRAs as necessary Lead, manage, coach, and mentor the team, including recruitment, onboarding, goal setting, training, and development Ensure the execution of training plans, SOP review, and understanding and adherence to SOP training matrix and all company policies and systems. Ensure quality deliverables, including identifying quality risks, and developing corrective action plans to prevent and/or correct deficiencies Collaborate with cross-functional members to support teamwork and project deliverables Maintain current knowledge of therapeutic areas, SOPs and ICH-GCP guidelines Ensures all aspects of trial delivery at the site management level, including monitoring, data collection and documentation, and site communications are conducted professionally and to the highest standard Set up and work closely with clinical trial physician committees e.g., Clinical Event Committee, Data Safety and Monitoring Board, and Steering Committee Participate in internal and external audits. Support and prepare clinical sites and internal staff for inspections Lead new system implementation e.g., Trial Master File Set quality and compliance goals for the trial and monitors/manages compliance Leads department-wide efforts to improve and refine existing tools to enhance trial management and communication Communicate status and issues to all organizational levels including management Solve complex problems within area of responsibility that require ingenuity and creativity Demonstrate multi-faceted approach to problem resolution Capable of generating a set of sound options and recommendations for managements consideration in problem resolution Provide executive summaries on project status as required. Ensure that Management Team maintain a clear understanding of the status of projects Requirements: Bachelors degree and at least 7 years of clinical research experience An advanced degree Experience in cardiovascular and/or heart failure clinical research Minimum 2 years of direct leadership/management experience or comparable experience Skills in the use of computer statistical, technical, and database applications Knowledge of the infrastructure and operational characteristics of contract research organizations and centralized clinical laboratories Knowledge of fiscal management and clinical study budgets Ability to develop and deliver both oral and written presentations Ability to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment Ability to establish data collection and management guidelines Ability to provide technical advice, guidance, and support to professional staff in area of specialty Knowledge of database concepts and formats Knowledge and experience of global regulations and standards affecting Medical Devices. Must have clinical trial management or QA / QM experience preferably within medical devices Excellent knowledge of ISO and local regulations required for clinical trials Proven record of compliance with, and enforcement of regulations in clinical trials For more information please contact Sinéad Cullen on or Skills: Clinical Trials Medical Devices Medical Device Clinical Trials



  • Galway, Ireland UniJobs Full time

    Unijobs on behalf of our public sector client are currently recruiting for the position of Clinical Research Nurse within the Galway City area. Contract is for an initial 3 month period, with potential for extension thereafter. Salary in the region of €42,000 - €72,000 dependant on experience. Annual leave accrued at 11.59%. 39 hours per week. Immediate...


  • Galway, Ireland Collins McNicholas Recruitment Full time

    Our client is looking to hire a Scientific Training Program Manager as they go through an exciting expansion of their business. The Training Program Manager will be responsible for reviewing current training, designing, implementing, and managing existing and new scientific training programs and training of colleagues within laboratories. This role focuses...

  • Project Manager

    3 days ago


    Galway, Ireland Context Language Solutions Full time

    Support to Connect Cultures We are looking for a full-time project manager to join our high-performing community interpreting team in the Galway area. To apply,please submit your CV and Cover Letter by 5pm, 24th January 2025, outlining how your motivation, experience and skills fit this role profile. The Role Interface with clients, suppliers and team mates....


  • Galway, Ireland Cpl Healthcare Full time

    Paediatric Physiotherapist - Galway A Paediatric Physiotherapist is required by Cpl Healthcare, in partnership with the HSE, for a new opportunity based in City East/Central Galway with HSE West and North West. Drivers license with access to own car is required. Job Responsibilities: 1. Complete assessment, intervention, and treatment for a range of...


  • Galway, Ireland FRS Recruitment Full time

    Store Manager - Co. Galway (Shoe Shop) This role will be a Full-Time Contract and requires flexibility, working 5 days over 7, with no late nights. This role suits a candidate with experience overseeing a team in a fast-paced, customer-facing environment. Reporting to the Operations Manager, you will be the driving force across the store, building strong...


  • Galway, Ireland Abbott Laboratories Full time

    About Abbott Abbott is a global healthcare leader, we are committed to helping people live their best possible life through the power of health. For more than 135 years, we have brought new products and technologies to the world: in diagnostics, nutrition, cardiovascular, medical devices and branded generic pharmaceuticals -- that create more possibilities...


  • Galway, Ireland CPL Full time

    Clerical Officer Our client, a public sector body, wishes to hire an experienced Clerical Officer who is immediately available for a full time, 35 hours per week, position on a temporary 3-month contract based in Merlin Park. RESPONSIBILITIES · Supporting the SEO in all administrative needs · Preparing of HR Forms · Ability to work...


  • Galway, Ireland Pale Blue Dot Recruitment Full time

    Our client is an industry-leading sampling and analysis organization. Due to unprecedented growth, the Company is currently hiring for a Training Program Manager. Responsibilities include but are not limited to: 1. Training Program Development and Delivery 1. Design and manage the delivery of comprehensive training programs on laboratory techniques,...


  • Galway, Ireland Collins McNicholas Recruitment Full time

    Human Resource Generalist - Galway City - Permanent Full-time or Part time - Onsite. As the Human Resource Generalist, you will play a pivotal role in fostering a positive work environment and ensuring the effective management of our client's Company workforce. This role involves overseeing all aspects of HR functions, from recruitment and onboarding to...


  • Galway, Ireland NUI Galway Full time

    Applications are invited from suitably qualified candidates for a full time Postdoctoral Researcher position with the Nanoscale Biophotonics Laboratory at the University of Galway. The position is funded by Taighde Éireann – Research Ireland, formerly Science Foundation Ireland, as part of the Downstream Protein Analysis - Polarized Emission Spectroscopy...

  • Executive Assistant

    2 days ago


    Galway, Ireland Hays Specialist Recruitment Ireland Ltd Full time

    Your new company Delivering top-tier clinical care and patient comfort. My state-of-the-art client offers a broad spectrum of medical services. Your new role Primary Contact: Act as the main liaison between the CEO, Executive Team, and internal/external stakeholders. Administrative Support: Provide comprehensive administrative assistance, including managing...


  • Galway, Ireland INFORM3 Recruitment Full time

    INFORM3 RECRUITMENT Junior Civil/Structural Engineer Job Location: Galway Sector: Consultancy Inform3 are seeking a Junior Civil/Structural Engineer for a busy civil and building design consultancy company to join their busy office in Galway. Client has over 20 years experience in consultancy looking for a candidate with a minimum of 2 years experience....


  • Galway, Ireland Rent The Runway Full time

    Founded in 2009, Rent the Runway is disrupting the trillion-dollar fashion industry and changing the way women get dressed through the Closet in the Cloud, the world’s first and largest shared designer closet. RTR’s mission has remained the same since its founding: powering women to feel their best every day. Through RTR, customers can subscribe, rent...


  • Galway, Ireland Ministry Brands Full time

    Principal Developer – e Commerce We are looking for an experienced Principal Developer to join our R&D development centre in Ireland. Our team in Ireland is focused on building the next-generation cloud-native Saa S platform aimed at purpose-driven organisations, leveraging new technology to bring innovative products to market. What you will do: This is a...


  • Galway, Ireland FRS Recruitment Full time

    I am seeking a CORU registered Occupational Therapist for the Galway City/ East network. The Occupational Therapist will be working with a well-established OT Department covering a Primary Care Caseload. Travel will be a requirement for this role. HSE Payscale 35 hour week, Mon - Fri Galway City Temporary Requirements: - Occupational Therapy...


  • Galway, Ireland Life Science Recruitment Full time

    Did you know that your Internet Explorer is out of date? To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser. Name: Surname: Email: Phone: Cv: Salary Expectations: Education: Experience: Current Location: Notice Period: Write here your cover note: If you would...


  • Cork, Galway, Dublin, Ireland Access Talent Group Full time

    This is an exciting opportunity to join a well-renowned company in the Irish market, providing growth opportunities to become a senior level engineer. You will work closely with key players on project design and delivery. Our client works in Building Services, Civil and Structural Engineering, Health and Safety Management, and Fire Safety. They secure...


  • Galway, Ireland Life Science Recruitment Ltd Full time

    Senior Quality Engineer Our client a medical device startup company is seeking a Senior Quality Engineer to join their team. Reporting to the Senior Quality Manager the Senior Quality Engineer will work across all stages of development, manufacture, and commercialisation. The candidate will support the Senior Quality Manager with maintaining the Quality...


  • Galway, Ireland Iaat Conference Postponed To 2022 Full time

    Description THE ROLEAre you a marketing maven ready to trade the cityscape for breathtaking landscapes? We're on the hunt for a seasoned Senior Marketing Executive to helm our strategic and digital marketing efforts. This is your chance to spearhead our marketing initiatives, drive digital transformation, and captivate audiences with compelling content...

  • Research Fellow

    3 days ago


    Galway, Ireland NUI Galway Full time

    Applications are invited from suitably qualified candidates for a part-time 0.75 FTE (75%), fixed-term position as a Research Fellow with the Centre for Health Research Methodology at the University of Galway, Ireland. This position is funded by the HRB and is available from 6th Jan 2025 to 30th June 2025. Salary: Research Fellow salary scale €63,958 –...