Data Manager for Clinical Trials

Psicro; Italia; In loco; EUR 34.000 - 52.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus potential

Incentive plans

Other benefits

Descrizione del lavoro

Psicro is seeking a Clinical Data Manager to oversee data handling in clinical studies. You will manage database setup, testing, validation, and coding of medical data, while coordinating with clients and vendors.

Required are a Life Science or Pharmacy degree and proven CRO data management experience, plus full English proficiency and strong organizational skills. Base salary ranges from €34,000 to €52,000 gross annually, with potential bonuses and benefits.

Competenze

• Full working proficiency in English.
• Experience managing clinical or medical data in a CRO is required.
• Strong organisational and time-management skills.

Mansioni

• 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.

Conoscenze

English proficiency

Organisational/time management

Independent work

Formazione

Life Science or Pharmacy degree

Strumenti

Medidata Rave

Oracle InForm

MS Office

Descrizione del lavoro

Clinical 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.

Responsibilities

• 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

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.

Benefits

• Additional compensation: bonus, incentive plans, and other benefits may apply.