Clinical Quality Assurance Manager Romania in România

*Clinical Quality Assurance Manager**Romania - Bucharest**Sponsor Dedicated* It is critical that, for all sponsored clinical trials, patient safety, high quality data and compliance with regulations are granted. The Clinical Quality Leader position has a significant impact in achieving those objectives. Under the guidance of the RCQM, the CCQM oversees all CQM activities in the respective country/cluster. The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities. Specific responsibilities include, but are not limited to: - Regulations & Processes:o Local expert for ICH‐GCP and local regulations (incl. impact assessment of new/updatedlocal regulations on local processes).o Leads continuous improvements activities at the country level and supports or co‐leadscontinuous improvements activities at the global/regional level. - Training:o Local training point of contact and the liaison between local country operations and theo In close cooperation with local country operations management, identifies local trainingneeds and initiates local training activities.o Supports onboarding of local country operations personnel (quality‐related topics). - Quality Control (QC) Activities:o In conjunction with the local country operations management, coordinates andoversees all QC activities (local quality plan) by ensuring a proper execution of the InhouseQuality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs).o In mutual agreement with local country operations management and the RCQM,performs QC activities (incl. QCVs). . - Audits & Inspections:o Primary point of contact for MRL Quality Assurance and Regulatory Agencies.o Manages and supports activities during the preparation / ongoing / follow‐up phase ofan audit or inspection. - Quality / Compliance Issue Escalation:o Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM. Compliance.o Local POC for escalations of Privacy Breaches that occurred in clinical trials, or supportslocal POC for escalations of Privacy Breaches, if necessary. - Education:o Bachelor's Degree or equivalent in relevant health care area. - Experience:o A minimum of 5‐8 years of relevant experience in clinical research including direct fieldmonitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.o Deep knowledge and understanding of Clinical Trial processes as well as qualitymanagement and control tools is required.o Demonstrated experience leading cross‐functional teams of business professionals.o Solid track record of initiating, planning and delivery of projects and knowledge ofproject management practices.o Ideally, experience in managing audits and inspections.o Ideally, experience in coordinating and delivering training sessions. - Skills:o Superior oral and written communication and people management skills in aninternational environment.o Excellent project management and organizational skills.o Excellent teamwork and leadership skills, including conflict resolution expertise anddiscretion.o Ability to analyze, interpret, and solve complex problems.o Ability to think strategically, objectively and with creativity and innovation.o Ability to proficiently interact with all levels of clinical research management and exertinfluence to achieve results. Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world. #LI-KU1