Manager Clinical Compliance in Holly Springs, NC

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Industry:

Pharmaceuticals & Biotech   •  

5 - 7 years

Posted 8 weeks ago

Job Description:


To monitor the compliance, quality and process efficiency of clinical trials run by Seqirus, communicate compliance/quality/performance metrics to functional areas, improve processes and ensure constant inspection readiness Work with functional areas to measure and analyse the compliance, quality and efficiency of the clinical processes, implement improvement plans and monitor the performance Perform risk assessment at the beginning of a clinical trial to develop adequate metrics to monitor compliance and performance, as well as to propose mitigation plans for the identified risks Monitor the compliance/quality/performance of the following critical aspects of a clinical trial by: Keeping the list of team members and ensuring that all personnel have the education, experience and training to perform their assigned tasks Keeping a list of all processes used in the conduct of the clinical trial(s) including vendors' processes Participating in the selection and qualification of the vendors, reviewing their processes, identifying possible risks, determining mitigation plans, defining quality/compliance/performance metrics and key Performance Metrics to monitor vendors' performance Monitoring Principal Investigator(s) compliance from the selection to the closure of sites by reviewing monitoring reports, protocol deviations, quality issues and other metrics (such as SAEs, queries) Managing non-compliance (audit findings, deviations, quality issues, events, Out of Trends Metrics), defining the compliance issue, requesting and reviewing investigation and root cause analysis, reviewing proposed corrective and preventive actions, overseeing the implementation of the CAPA and verifying, when needed, its efficiency (via effectiveness checks) Overseeing the quality of monitoring, in collaboration with Clinical Operations, by reviewing monitoring reports, audit reports and site metrics and qualifying CRA performance. Ensuring the Quality of data (Data Management and Biostats) by reviewing documents (i.e. Data Management Plan, validation plan and associated documents, etc.) and records Ensuring that the processes of Safety oversight, reporting and surveillance are complete, accurate and adequate Overseeing the management of Investigational Product in collaboration with Clinical Vaccine Management and eClinical Technology to ensure the quality and integrity of the drug, procurement accuracy and proper randomization Measuring quality, completeness, timeliness and metrics of the eTMF and other study documentation management systems.

Qualification:

• Bachelor degree , or equivalent, in Science related discipline preferred; Post graduate qualifications in scientific or business related field preferable.

• 5+ years experience working in a Clinical Operations environment is required.

• Global Clinical Operations experience is essential.