Clinical Data Manager
Avania Clinical is a leading contract research organization (CRO) that offers exciting career opportunities for professionals in the clinical research industry. With a global footprint, a diverse range of therapeutic areas, and expertise in supporting medical device and MedTech solutions, Avania Clinical provides a dynamic and rewarding work environment that fosters growth, innovation, and collaboration.
Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients' lives worldwide.
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
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 3 – 5+ 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
Full, Comprehensive Benefits
Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients' lives worldwide.
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
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 3 – 5+ 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
Full, Comprehensive Benefits