Lead Data Manager

**Job Description:**

**Company Description:**
PSI CRO AG is a global organization with over 2,700 employees worldwide. Our team comprises scientists, strategists, creatives, and innovators dedicated to changing lives and redefining success in the clinical research industry. We value individual brilliance while fostering teamwork across all our business operations. Embracing challenges is at the core of our work culture as we strive to make a difference every step of the way.

**Lead Data Manager Responsibilities:**
As the Lead Data Manager at PSI CRO AG in Italy, 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 role will involve reviewing study documents, developing Data Management plans and guidelines, coordinating user acceptance testing, supervising data entry processes for quality control purposes, managing data validation activities including query resolution, handling non-CRF electronic data transfers and database edits. Furthermore, you will be responsible for SAE reconciliation and ensuring compliance with coding dictionaries.

**Qualifications and Skills Required:**
To excel in this role, you must possess a College or University degree or equivalent training with at least 3 years of experience in full scope data management responsibilities within international EDC studies. Proficiency in CDM/EDC systems such as Medidata Rave or Oracle Inform is preferred along with project data management experience. Strong organizational skills are essential along with proficiency in English.

**Join Us:**
If you are looking to advance your career in clinical research and develop new skillsets while growing within a dynamic organization like PSI CRO AG, this opportunity is ideal for you. We encourage qualified candidates who meet the specified qualifications to apply for the Lead Data Manager position and become part of our innovative team shaping the future of healthcare through impactful research endeavors.

• 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
• 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
• Development of Data Validation Plan/Edit Check Specifications
• Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol

• Data Management
• Communication Skills
• Clinical Research Knowledge
• Organizational Skills
• Proficiency in English

Seniority Level: Middle Management

• Senior Level
• Executive Level

Job Functions: Data Management

• Communication
• Quality Control

Industries : Clinical Research

• Healthcare
• Pharmaceuticals