Lead Data Manager

PSI CRO AG, a global leader in clinical research, is seeking a Lead Data Manager to join our dynamic team in Hungary. With over 2,700 employees worldwide, we are a diverse group of scientists, strategists, creatives, and innovators who value individual brilliance while fostering strong teamwork. Our mission is to change lives and redefine success in the challenging field of clinical research.

As the Lead Data Manager, you will oversee all data management activities for large, complex studies with minimal supervision. You will serve as the primary communication point for project teams and company departments regarding clinical data management. Additionally, you will coordinate data management activities related to EDC development, data collection, cleaning, reconciliation, database lock, and final integrated database generation.

Your responsibilities will include reviewing study documents, developing project-specific guidelines and instructions, coordinating user acceptance testing, supervising data entry personnel, conducting data validation activities, managing non-CRF electronic data handling processes, overseeing database edits and CRF reviews, coordinating SAE reconciliation tasks, and ensuring accurate coding of medical data using coding dictionaries.

Furthermore, you will liaise with the Document Center for TMF maintenance purposes and participate in internal and client audits/inspections related to Data Management. You will also be responsible for training Assistant Data Managers and providing project-specific training to investigators and clinical teams on CRF completion. Proficiency in English is required along with organizational and managerial skills.

Join PSI CRO AG to advance your career in clinical research by developing new skillsets while growing within our organization. If you have at least 3 years of experience in international EDC studies with a strong background in CDM/EDC systems such as Medidata Rave or Oracle Inform preferable – we invite you to apply for this exciting opportunity as a Lead Data Manager at our innovative company.

• At least 3 years of experience of full scope of data management responsibilities in international EDC studies
• At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
• Project data management experience is a plus
• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
• Full working proficiency in English
• Organizational and managerial skills

• Primary communication point for project teams and company departments with regard to clinical data management
• Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables
• Liaison with Document Center with regard to maintenance of TMF and eTMF
• Training of Assistant Data Managers

• Data Management
• Clinical Trials
• EDC Development
• Database Lock
• Quality Control

Seniority Level: Senior Level

• Middle Management
• Executive Level

Job Functions: Data Management

• Clinical Data Management
• Project Data Management

Industries : Clinical Research

• Healthcare
• Pharmaceutical