What are the responsibilities and job description for the Clinical Data Manager position at Avania Career Center?
Avania are hiring Clinical Data Manager
Salary Range up to $90,000 Annual Performance related bonus Benefits
Do you want to work in a global and fast-growing team within Avania to support Clinical Trials in the MedTech industry?
The Data Management EU team consists of 15 Data Managers closely working with the global Data Management team of 25 people.
The Clinical Data Manager (CDM) is responsible for overseeing the collection, review, query management, and cleaning of trail data to ensure accuracy, completeness, and compliance with regulatory standards.
The Clinical Data Manager role plays a critical part in ensuring data integrity throughout the lifecycle of clinical studies, coordinating Data Management activities and acting as the main point of contact for study teams.
The Clinical Data Manager role will perform the following tasks with support and supervision of more senior staff:
- Create and maintain the Data Management Plan (DMP)
- Create and maintain other DM study plans including the Clinical Data Coding Plan, External Data Transfer Plan, CRF Completion Guidelines (CCG), Data Validation Plan (DVP) and User Acceptance Testing (UAT) Plan
- Design and review Case Report Forms (CRFs)
- Define data validation specifications for programmed checks
- Define data validation specifications for manual form-by-form checks and manual listings checks
- Perform UAT on EDC study database
- EDC user account management, create new users, deactivate nonactive users, account administration
- EDC user account periodic review (ISO27001)
- Perform training on the EDC study database for site and other end users
- Act as EDC helpdesk for site and other end users
- Define specifications for Power BI dashboard setup, including high level content descriptions, visuals, definitions (e.g. definition of ‘enrolled’), data sources and refresh policy
- Perform data review in the study database and by use of manual review listings, as defined in the DVP
- Add queries where applicable and perform query management
- Produce deliverables in accordance with Standard Operating Procedures (SOPs)
- Maintaining compliance to SOPs, ISO 14155, ISO13485, ISO27001 and ISO9001 standards