Do you have Clinical Data Management experience and would like to be part of a dream team in a growing and exciting Medical Devices company? Apply now!
Job Description
The Clinical Data Manager (CDM) leads end to end data management activities on diverse scope projects.
Responsibilities
- Collaborate with Clinical Monitors, Clinical Study Managers, Clinical Research Associates and Biostatisticians to ensure all data is complete, timely, and accurate.
- Enter data from research studies into the proper Clinical Data Management Systems.
- Review data for quality and resolve discrepancies.
- Assist in development, maintenance and management of case report forms/study worksheets to ensure consistency with the protocol and database.
- Assist in development of the Study Requirements Specification (SRS).
- Contribute to study-specific data management processes including Data Management Plans, User Guides, Case Report Form Completion Guidelines, and other study documentation.
- Generate data output and coordinate data output documentation.
- Perform database validation under the guidance of the Clinical Database Developer or Data Management department leadership.
- Contribute to the review and creation of processes related to Data Management.
- Perform project in compliance with regulations.
- Support routine internal audits of projects.
- Ensure that the product/deliverable is the best it can be given time and budget constraints.
- Function at a level that affords respect by internal NAMSA Associates/team members.
- Communicate project/team issues to Project Manager and/or Management.
- Function as a productive project team member.
- Keep project plan or study calendar updated.
- Contribute to presentations, including preparation, assembling slides, and speaking.
- Network with peers in the medical device industry.
- Inform manager or marketing colleagues of potential opportunities.
Requirements
- Bachelor's degree or equivalent experience in a related field, with a minimum of 3-5 years of relevant experience.
- Fluency in English and local language, if different, required.
Technical Competencies:
- Familiar with clinical trial processes such as site selection/qualification, site initiation, monitoring, close-out.
- Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC/REB personnel.
- Technically conversant with respect to Clinical Data Management Systems.
- Existing right to work in Europe required
Benefits
- Fulltime position in full remote
- Open for employee and freelance profiles
- A balanced salary package based on your capabilities and experience
Vacancy number: 20920