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
- 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: firstname.lastname@example.org
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