Beschreibung
Clinical Data Manager - Risk Based Quality Management System (RBQM)
Project Responsibilities:
5 days per week - fully remote - Freelance
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.
- 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