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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Clinical Project Manager


Reference:SCABNA-744763 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Senior Clinical Project Manager
Our Dublin based client are currently recruiting for a Senior Clinical Project Manager to join their team on a permanent basis. As Senior Clinical Project Manager you will be responsible for maintaining knowledge and ensuring compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures), study protocols and project-specific procedures, manage assigned studies in line with SOPs and manage successful execution of one or multiple projects. The role reports directly into the Head of Operations and Clinical Programs.


Responsibilities

  • Manage assigned studies from concept to final study report in line with ICH-GCP, regulatory requirements, applicable guidelines, Standard Operating Procedures (SOPs), study protocols and project-specific procedures
  • Develop and maintain strong relationships with external stakeholders to identify new studies and manage ongoing collaborations
  • Contribute to the oversight and execution of key operational strategies and processes and take on a leadership role as required
  • Lead protocol development for assigned studies and input into other protocol reviews when required
  • Develop and execute study plans including setting project goals, leading risk assessment and management, planning resources and timelines, and study team oversight
  • Develop and manage role and project-specific training
  • Overall responsibility for management of essential documents and Trial Master File related to assigned studies
  • Oversee the process of site visits and documentation of the visits
  • Pre-emptively identify potential issues and proactively manage resolutions and put in place, where possible, measures to minimise issues and risk for assigned studies
  • Contribute to preparation for audits and inspections, conduct, and lead follow-up as required both internally and at investigational sites for assigned studies.
  • Draft and finalise budgets, contracts and roles and responsibilities prior to commencing study activities and manage throughout the lifecycle of the study.
  • Oversee Regulatory and Ethics committee submissions for assigned studies.
  • Responsible for vendor identification and management where required.
  • Take all reasonable precautions to ensure patient confidentiality is maintained.
  • Input and coordination of the development and update of departmental and cross-functional SOPs as required
  • Represent the organisation at external meetings and conferences as required
  • Represent the Clinical Operations Department when called upon
  • Update the Head of Clinical Operations on the status of all clinical trial activities
  • Identify and communicate scientific misconduct according to the organisations policies
  • Develop and execute study plans including setting project goals, risk assessment and management, planning resources and timelines, and study team management
  • Manage performance and development of employee
  • Manage project-specific training and mentoring
  • Contribute to preparation for audits and inspections as required
  • Evaluate and document investigator and site selection
  • Overall responsibility for management of essential documents and Trial Master File
  • Oversee the process of study initiations, monitoring and close-out
  • Develop and maintain study monitoring plan for the duration of the study lifecycle
  • Review and sign-off initiation, monitoring and close-out reports and documents
  • Participate in process of protocol development
  • Identify issues and manage the resolution process for studies under their supervision
  • Ensure compliance with all applicable SOPs
  • Input in SOP development and updates where appropriate
  • Ensure budget agreements and contracts are in place and roles and responsibilities documented prior to commencing study activities
  • Manage the study budget and associated financial activities for studies under their supervision when applicable
  • Oversee Regulatory and Ethics committee submissions if applicable
  • Confirm the necessary processes are in place for study drug and other supplies for studies under their supervision when applicable
  • Take all reasonable precautions to ensure patient confidentiality is maintained
  • Organise and attend meetings as required
  • Prepare and make presentations as required
  • Update Clinical Program Lead on the status of all clinical trial activities
  • Identification and communication of scientific misconduct
  • Maintain strong relationships with external stakeholders
  • Prepare study reports as required

Requirements
  • Science and/or medical or nursing background.
  • Minimum of 7 years’ clinical research experience including 2 years in Clinical Project Management
  • Proven management experience including
    • Direct line management of clinical research staff
    • Oversight of cross-functional operational activities
    • Resource calculation and financial budgeting
    • In-depth knowledge of the Irish clinical trials environment.
    • Excellent communication skills with the ability to represent the company at an international level