Clinical Research Program Manager
Our client, a medical device organisation, is currently recruiting for a Clinical Research Program Manager to join their team on a permanent basis.
This organisation is fast growing and dynamic with an extensive research, development and clinical program planned.
As Clinical Research Program Manager, you will be responsible for leading and being 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 guidelinesCoordinate and supervise clinical research support team, providing project-specific training when applicableProvide training to CRO partner resources such as insourcing CRAs, internal team members including fixed-term contractorsEnsure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and proceduresEnsure 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 reportingEnsure supplies and equipment are available for studies as necessaryIdentify and provide solutions to clinical trial issues and/or risksSubmit IRB applications and stay up to date with protocol amendments and inform/train staff when modifications are required.
Work closely with sponsors, CROs, and CRAs as necessaryLead, manage, coach, and mentor the team, including recruitment, onboarding, goal setting, training, and developmentEnsure 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 deficienciesCollaborate with cross-functional members to support teamwork and project deliverablesMaintain current knowledge of therapeutic areas, SOPs, and ICH-GCP guidelinesEnsure 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 standardSet up and work closely with clinical trial physician committees e.g., Clinical Event Committee, Data Safety and Monitoring Board, and Steering CommitteeParticipate in internal and external audits.
Support and prepare clinical sites and internal staff for inspectionsLead new system implementation e.g., Trial Master FileSet quality and compliance goals for the trial and monitor/manage complianceLead department-wide efforts to improve and refine existing tools to enhance trial management and communicationCommunicate status and issues to all organizational levels including managementSolve complex problems within area of responsibility that require ingenuity and creativityDemonstrate a multi-faceted approach to problem resolutionCapable of generating a set of sound options and recommendations for management's consideration in problem resolutionProvide executive summaries on project status as required.
Ensure that Management Team maintains a clear understanding of the status of projectsRequirements: Bachelor's degree and at least 7 years of clinical research experienceAn advanced degreeExperience in cardiovascular and/or heart failure clinical researchMinimum 2 years of direct leadership/management experience or comparable experienceSkills in the use of computer statistical, technical, and database applicationsKnowledge of the infrastructure and operational characteristics of contract research organizations and centralized clinical laboratoriesKnowledge of fiscal management and clinical study budgetsAbility to develop and deliver both oral and written presentationsAbility to communicate and interact competently and professionally at all levels within a broad, complex clinical research environmentAbility to establish data collection and management guidelinesAbility to provide technical advice, guidance, and support to professional staff in area of specialtyKnowledge of database concepts and formatsKnowledge and experience of global regulations and standards affecting Medical Devices.
Must have clinical trial management or QA/QM experience preferably within medical devicesExcellent knowledge of ISO and local regulations required for clinical trialsProven record of compliance with, and enforcement of regulations in clinical trialsFor more information please contact Sinéad Cullen on +353879500821 or ******
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