Clinical Data Manager

Medevise Consulting is looking for an Clinical Data Manager to join our growing international team.

Job Purpose

The Clinical Data Manager is responsible for supporting the planning, set-up, conduct, and close-out of clinical data management activities for clinical investigations and post-market clinical activities, primarily involving medical devices.

Working under the supervision of the Lead Clinical Data Manager, the Clinical Data Manager ensures that clinical data are collected, reviewed, documented, and managed in accordance with the study protocol, Data Management Plan, applicable procedures, and relevant regulatory and quality requirements.

The Clinical Data Manager contributes to the delivery of high-quality, reliable, traceable, and inspection-ready clinical databases.

Key responsibilities

The list of responsibilities described below is not exhaustive and will be adapted :

• Contribute, in collaboration with the Lead Clinical data Manager, to the development and implementation of data standards, SOPs, templates, and software.
• Review study documentation relevant to data management, including the protocol, and contribute to the development of study-specific data management documentation (Data Management Plan, eCRF specifications, edit check specifications).
• Configure and maintain study databases within the assigned EDC system.
• Be involved in the design and configuration of eCRFs (electronic Case Report Forms).
• Program or configure data validation checks within the EDC (Electronic Data Capture) system.
• Participate in User Acceptance Testing (UAT).
• Support database release and Go-Live.
• Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries, and resolution of data discrepancies in collaboration with the Clinical Project Managers and the Clinical Research Associates (CRAs).
• Utilize programming skills and appropriate tools, such as analytics and reporting tools, to provide information as required to support study team activities.
• Perform database review activities, such as centralized monitoring and database status reporting.
• Perform database cleaning activities and support efforts involving cross-functional study team members to ensure the completeness, consistency, and accuracy of the clinical data captured.
• Support database lock activities.
• Coordinate with the Biostatistician and Statistical Programmer on dataset requirements, data structure, data cleaning, data transfers, data validation, and database readiness, as applicable.
• Support the preparation and review of datasets and data transfers required for interim and final statistical analyses.
• Ensure that the Data Management documentation is complete, accurate, and filed in the Trial Master File.

Who you are

We're looking for someone with :

• strong track record in clinical data management (3+ years),

• experience with EDC system and eCRFs configurations,

• Knowledge of clinical trials and medical device and/or drug development processes,

- Good interpersonal communication & excellent team player spirit

• Familiar with various data visualization, analytics, and reporting tools.

More details :

• Location: Strasbourg city centre or home-based
• Permanent position, 5 days/week
• International environment (EU, UK & US)
• Hybrid work possible or fully remote possible

Rémunération : à partir de 35 000,00€ par an

Avantages :

• Prise en charge du transport quotidien

Langue:

• Anglais (Requis)

Lieu du poste : Télétravail hybride (67000 Strasbourg)