Clinical Data Manager

1 week ago

Australia Opis S.r.l. Full time
Job Description

Job Title: Clinical Data Manager

Company: Opis S.r.l.

Job Type: Full-time

Location: Remote (Italy)

About Us:

Opis S.r.l. is a leading biotech-focused CRO providing premium trial management services for multi-country clinical trials. We are a science-driven company with a strong focus on innovation and quality.

Job Summary:

We are seeking an experienced Clinical Data Manager to join our team. The successful candidate will be responsible for ensuring the quality and integrity of clinical data, ensuring compliance with regulatory guidelines and company SOPs.

Key Responsibilities:

  • Data Management: Ensure data is managed in compliance with applicable standards (e.g., CDISC), regulatory guidelines, and company SOPs.
  • Document Preparation: Prepare Data Management documents (CRF, Data Management Plan, Data transfer specifications, etc.).
  • Database Design: Design the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in cooperation with the Sponsor and the study team.
  • Database Validation: Prepare and validate the eCRF/clinical databases and related tools.
  • Change Management: Prepare and manage change requests of the database.
  • Data Cleaning: Perform data cleaning activities.
  • Coding: Perform coding activities of medications and medical terms using medical dictionaries.
  • SAE Reconciliation: Perform SAE reconciliation when required.
  • Database Lock and Freeze: Manage under supervision database lock and freeze before data analysis.
  • Documentation: Prepare, maintain, and archive data management documentation.
  • Quality Control: Perform quality controls according to the Data Management Plan.
  • Stakeholder Liaison: Liaise with Sponsor and external stakeholders regarding data management activities.
  • Project Tracking: Track activities and milestones to ensure timely project deliverables.
  • KPIs and Metrics: Ensure that KPI and metrics for the assigned studies are met.
  • Training and Development: Perform and complete on time all required trainings (study trainings, training on company SOPs, all other applicable trainings) by the assigned due date.
  • Time Tracking: Ensure daily completion of TRACK system, correct entry of appropriate billable and non-billable time.

Requirements:

  • Education: Bachelor's degree.
  • Experience: At least 1 year of experience in CRO, biotech, pharma, research institutes in a similar role is preferred.
  • Knowledge and Skills: Knowledge of ICH-GCP/ISO14155 and techniques for data management of clinical studies/investigations. Knowledge of SAS system is a plus. Excellent knowledge of the Microsoft package. Excellent communication and team-working skills. Strong commitment to quality. Flexibility and propensity for innovation. English language (fluent reading, writing, and verbal skills). Planning and organizational skills. Communication skills. Result-oriented. Team-working oriented.

What We Offer:

We offer a competitive salary with other benefits/bonuses and the opportunity to develop your professional career with an expanding and growing company.

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