Avania are hiring Clinical Data Manager

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

Candidates who offer a combination of the skills, knowledge and experience listed below are encouraged to apply to our Clinical Data Manager role . With our continued growth we are hiring talent to join us on our journey and grow with us.

We seek -

• Relevant degree in (para)medical life science or health related field

• Minimum 0 – 2+ years of work experience in clinical research, in the pharmaceutical, biotechnology or device industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

• GCP-ICH-E6, FDA regulations and ISO 14155,13485,27001 and 9001 knowledge where applicable

• Knowledge of regulatory regulations and guidelines on medical devices

• Understanding of basic statistics

• Fluent in English, spoken and written

• Focused and persistent

• Strong attention to detail

• Strong organizational and time management skills

• Strong interpersonal and communication skills (oral and written)

• Proactive and strong problem solving skills

• Ability to work under the pressure of meeting deadlines sponsors, site staff,  contractors, other Avania departments

• Ability to manage multiple projects concurrently

We offer -

• The opportunity to work in an innovative, fast-growing and rewarding industry
• A dynamic and enthusiastic global team that fosters collaboration and the opportunity to work with experts across many specialties
• Exchange of knowledge and ideas to help employees grow and advance their careers, backed with training and other development opportunities
• Competitive compensation and benefits package (details shared during the interview process)
• Some roles offer the opportunities for travel
• Ask us about our hybrid and fully remote work opportunities

We look forward to receiving your application!

#LI-DNI