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 management’s 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

• Bachelor’s 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