Clinical Data Manager - Risk Based Quality Management System (RBQM) Project Responsibilities: Project Goal: Develop a strategy for implementing Risk Based Quality Management System (RBQM) and optimize related technologies, processes, and standards. Consultation and Knowledge Transfer: Collaborate with Department Leads to create the RBQM implementation strategy. Data Management Delivery: Oversee the entire process of data management services for assigned studies or projects. Provide technical guidance to CROs and other vendors to ensure high-quality deliverables are completed on time and within budget. Study Activities: Manage assigned study tasks related to Data Management, including setup, execution, and closure. Deliverables: Ensure timely, budget-compliant, and accurate completion of Data Management tasks such as creating Data Management Plans, specifying and building databases, handling interim data cuts, locking databases, and archiving studies. Leadership in RBQM: Lead RBQM initiatives by incorporating external industry insights to establish best practices and develop innovative solutions. Qualifications: Language Proficiency: Excellent command of the English language. RBQM Knowledge: Strong understanding of RBQM concepts and practical experience in RBQM implementation, ideally as an RBQM lead or in a similar role. Data Integrity and GDPR: Good grasp of data integrity principles and GDPR regulations, along with strong technical skills in handling data from CROs and other third-party vendors. Project Skills: Proficient in continuous improvement, project management, change management, and risk management. Study Expertise: Proven experience in the design, conduct, and execution of studies. Clinical Research Knowledge: Extensive understanding of the principles, concepts, methods, and standards in Clinical Research. Communication Skills: Excellent oral and written communication skills, capable of simplifying complex concepts for clear understanding. 5 days per week - fully remote - Freelance