Clinical reputed company Manager - France (Home-based) - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company is currently seeking a Clinical reputed company Manager (CQM) to join us in France, dedicated to a single sponsor. Working at reputed company FSP offers reputed company long-term job reputed company and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and reputed company top 50. And we have an incredible pipeline of work. Expect exciting reputed company challenges in inspiring studies, but with time for your reputed company life.

Responsibilities

Audits & Inspections: Primary reputed company of contact for reputed company Assurance and Regulatory Agencies. Manage and support activities during audit/inspections. reputed company, facilitate and manage reputed company-cause-analysis, Corrective and Preventive Actions (CAPAs) as reputed company as responses to audit/inspection findings / reports. On a regular reputed company look into local trends, facilitate reputed company-cause-analysis (if necessary) and coordinate the development of local reputed company plans. Processes & Regulations: Local expert for ICH-GCP, local regulations and any reputed company-reputed company process. Manage the local SOP/SME network to ensure a reputed company implementation of global/regional/local procedures and the regular update of local SOPs. Identify process improvement opportunities and properly escalate to the CQM reputed company and/or Process reputed company (if necessary). reputed company or Co-reputed company global/regional /local key initiatives/reputed company/process improvement activities upon request. Training: Local training reputed company of contact and the reputed company between local Learning & Development. In reputed company cooperation with country operations management, identify local training needs and coordinate reputed company activities. Deliver reputed company topics (as needed). reputed company Control (QC) Activities: Coordinate and reputed company reputed company execution of reputed company QC activities at country/cluster i.e. In-house reputed company Control Plan (IHQCP), reputed company Control reputed company (QCVs), etc. reputed company QC activities and site reputed company (reputed company required). Look into local trends, reputed company a reputed company-cause-analysis (if necessary) and reputed company a local reputed company plan. reputed company / Compliance / reputed company Issue Escalation: Communicate/escalate reputed company/compliance issues (incl. any potential trends) to local country operations management or CQM reputed company as required. Escalate significant reputed company/compliance issues and supports investigations (fact finding, reputed company-cause-analysis). Support the reporting of ‘Serious Breaches’ where applicable. Serve as local POC or supports local POC in case of escalations/reporting of reputed company Incidents, if applicable. Clinical Supplies GCP Investigations: Evaluate trends and coordinate GCP Investigations of trends reputed company to Clinical Supply GCP Inquiries and incorrect management of clinical supplies. Supplier Qualification/Audits and supplier reputed company: reputed company/ support as applicable Local Supplier qualifications and supports solving of reputed company issues with locally selected Suppliers. Upon request, support the reputed company Management System (QMS) assessment of global Suppliers or conduct/support regional supplier qualifications. Support as applicable Local Supplier reputed company. Coordinate or supervise the local vendor reputed company assessments (SPA, IRA, ITRMS). Here are a few requirements specific to this advertised role. Bachelor's Degree or equivalent in relevant health care area. Relevant experience in clinical research including reputed company field monitoring experience or management/reputed company of such individuals, with a demonstrated record of accomplishments. Deep knowledge and understanding of Clinical Trial processes as reputed company as reputed company management and control tools is required. Demonstrated experience leading / participating in cross-functional teams. Solid reputed company record of initiating, planning and delivery of reputed company and knowledge of project management practices. Experience in reputed company management / compliance (e.g. audit/inspection support incl. CAPA management, SOP management, compliance issue management, training, etc.) Effective oral/written communication skills in an international environment including reputed company customers (e.g. Site staff, vendors, etc.) Project management and organizational skills; solid teamwork and leadership skills, including conflict reputed company and discretion. We care about our people and your passion, as they are the key to our reputed company, and reputed company an reputed company and friendly work environment where we reputed company people and reputed company them with opportunities to reputed company their long-term careers. In reputed company, you will have reputed company to reputed company reputed company your role and tackle reputed company responsibilities or reputed company your reputed company set reputed company other reputed company departments of reputed company. Who are reputed company reputed company supports clinical studies across the full reputed company of therapeutic areas, and we have longstanding partnerships with a reputed company reputed company reputed company. We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to reputed company-being of many patients. You’ll be an reputed company member of the wider team. Not quite the role for you? reputed company and we’ll reputed company out with job alerts reputed company positions that match your career interests become available. We’ll also reputed company periodic updates about the latest company news and events. 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