Bucuresti, ROM
11 hours ago
Study Start Up Manager, IQVIA Biotech
**Manager, Study Start Up – IQVIA Biotech** **Location: Serbia, South Africa, Hungary & Romania** **Work Model: Home-based, Hybrid** **Job Description Summary** The Manager, Study Start Up oversees a dedicated department responsible for delivering high‑quality site activation activities. This role ensures operational excellence, team performance, and compliance with regulatory requirements, while driving short‑term objectives and supporting broader clinical research goals. **Job Overview** The Manager, Study Start Up is responsible for leading a team or functional unit that performs site activation activities across assigned clinical research projects. This role sets goals and objectives for staff, ensures quality and compliance, and oversees training, resource allocation, and continuous improvement. The manager is expected to solve moderately complex challenges and apply strong leadership, planning, and coaching skills. **Essential Functions** **Team Leadership & Performance Management** + Manage staff responsible for site activation activities in alignment with organizational policies and applicable regulations. + Plan, assign, and direct work; assess performance; guide professional development; and handle employee relations and disciplinary actions where needed. + Participate in hiring processes, including candidate evaluation and interviews, ensuring effective onboarding and training for new employees. **Training, Tools & Compliance** + Ensure staff have appropriate tools, training, and system access to perform their responsibilities. + Oversee execution of training plans, SOP reviews, and training activities as required. + Monitor staff performance quality through regular review and evaluation of work deliverables. **Operational Oversight & Resource Allocation** + Participate in resource planning and assign team members to clinical research projects based on experience and skills. + Identify quality risks, resolve issues, and create corrective action plans to address performance gaps. + Ensure staff meet defined workload, delivery, and quality metrics, reporting findings as required by clinical operations leadership. **Process Improvement & Problem Solving** + Lead moderate process, system, or workflow improvements to enhance team and departmental performance. + Address difficult problems requiring understanding of broader operational and functional considerations. + Demonstrate management best practices, including prioritization, work scheduling, coaching, and consistent execution of operational processes. **Regulatory Expertise** + Maintain strong working knowledge and application of **GCP/ICH guidelines** and all applicable regulatory requirements relevant to site activation and clinical trial execution. **Qualifications** + **Bachelor’s degree** in a scientific discipline or healthcare‑related field preferred. + **Typically 3–7 years of relevant experience** in clinical research, site start‑up, clinical operations, or related functions. + Proven ability to lead teams, manage performance, and drive operational excellence. + Strong understanding of regulatory guidelines (GCP/ICH) and clinical research processes. **Why IQVIA Biotech?** Join a mission-driven organization dedicated to improving patient outcomes through innovative clinical research. At IQVIA Biotech, you will work in an agile environment with the support of global resources and the opportunity to grow your career while making real impact. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled
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