Data Manager for Clinical Trials

Location: Milan, Lombardy, it, Remote

Company Description

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

Job Description

Clincial Data Manager plays a critical role in the clinical research project. If you are detail-oriented and committed to quality, able to work with large volume of clinical or medical data, you might be the professional we are looking for.

Please submit your CV in English

Responsibilities will include:

• Track database set-up, testing, maintenance and data entry
• Communicate with clients, project teams and vendors on data management matters
• Review study documents, design and develop project specific guidelines and instructions
• Design eCRF, Data Management and Data Validation Plans and test EDC databases
• Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
• Code medical data
• Track and report metrics leading to database lock
• Coordinate the processing, dispatch and archiving of CRFs/queries
• Maintain Clinical Data Management working files
• Perform database QC checks, prepare and attend audits
• Train site staff and project teams on CRF completion and data management topics

Qualifications

• College/University degree (Life Science, Pharmacy degree is a plus)
• Demonstrated experience of managing clinical or medical data in a CRO is a must
• Full working proficiency in English
• Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)
• Proficiency in MS Office applications
• Organisational and time management skills
• Ability to work independently and multi-task

Additional Information

Base salary range: €34,000 - €52,000 gross annual salary.
Actual compensation: The salary offered within the stated range will depend on objective, job-related criteria, including demonstrated competencies, qualifications, and skills relevant to the position.
Additional compensation: bonus, incentive plans, and other benefits may apply.