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Scientific & Laboratory

Job Description

A Director Clinical Compliance (GCP) is required to join our Dublin clients. You will support and work with their clinical study management teams and teammates across R&D Quality and Compliance. Please contact Diarmuid Buckley for full details.

Role of this position

  • Active member of the R&D Quality and Compliance Clinical management team
  • Lead Clinical Compliance activities and compliance staff in one or more therapeutic areas. Handle multiple projects and ensure overall and timely completion of tasks.
  • Works closely with compliance staff and clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
  • Support deviation identification, reporting, and CAPA development
  • Responsible for ensuring the development of audit strategy plan(s) and ensuring timely execution of plans for programs.
  • Oversees GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
  • Represent Regulatory Compliance in Working Groups as appropriate
  • Supervise, develop, train and manage internal staff as appropriate.
  • Ensure oversight of contracts auditors.
  • Effective compliance reporting to senior management and relevant quality governance forums

JOB REQUIREMENTS

  • BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS).
  • Must have significant GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience required. Bio-pharma sponsor or CRO experience required.
  • Significant experience with pediatric clinical trials strongly preferred.
  • Recognized as an expert resource on a range of clinical compliance topics.
  • Ability to travel approximately 25% required.

Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Scientific & Laboratory

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie