COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career? We are currently recruiting for a Clinical Team Lead ready to join our constantly growing CoSource team. This is a full-time, permanent and office-based position at our Client’s office in South Paris.
Responsibilities in the Quality department
50% Quality Assurance function
Actor of the quality meetings and quality days of the clinical operations department Assist in preparation and conduct of the audit Contribute to the resolution of the audit CAPA with the CRAs Train the department on all quality aspects and new SOPs Assist the CRA team with the monitoring issue resolution.
50% Subject Matter Expert function
Quality control on all CTMS on an ongoing basis, for QA audits and for client’s department audits Quality report: regular extractions and action plan to track the activities (MVR/Issues and CSR on monthly basis plus client department Quality report on quarterly basis);
Assisting the client local record specialist to follow-up the completeness of eTMF;
Implementation of the new tools and support to the Clinical Operations Department;
RBM: Implementation of the new process and support the team at Clinical Operations Department level;
Extractions: regular extraction to answer to external and internal requests like: attractively survey, global request, monthly and/or quarterly highlights, follow of KPI for the trials and/or department Following client training requirements and certifications, SOPs development and implementation;
Participating to the client department meetings.