Senior Clinical Data Manager, Europe Based (all genders)
Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central- and Eastern Europe.
We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS, based on experience and expertise.
Description of the tasks / routine work:
- CRF design, Production of the DMP & writing of the edit checks specifications
- Review of draft protocols and CRF’s for consistency and accuracy. Review CRF design where appropriate.
- Set-up and maintenance of the Project Binder and all related documentation.
- Review the annotated CRFs.
- Testing of clinical study database.
- Testing of edit checks and data listings.
- Support clinical data programmer with programming activities and database setup.
- Defining electronic data transfer specifications. Liaison with contract laboratories and other providers of electronic data to co-ordinate the receipt ensuring that it is complete, consistent, in the required format and received in a timely manner in order for project timelines to be met.
- Be involved in the processing of clinical data including CRF review, query generation and resolution, review of electronic data, medical coding and quality control procedures.
- Generation of project status reports, and provides them to the corresponding project manager.
- Liaising with the project team members and the Data Management Team Leader to ensure that the status of the study and the goals and timelines are fully understood by all.
- Closing and locking of the databases and all activities related to the final cleaning of the data in preparation for lock including direct contact with sites to resolve outstanding queries.
- Training and day to day mentoring of clinical data managers to help them in the development of their tasks.
- Set an example to others in clinical data management with commitment to quality and customer focus.
- Liaise with clients in all project technical aspects, keeping posted the Data Project Manager in all communications.
- Any other task requested by line manager.
- The following project positions could be covered by the Senior Clinical Data Manager:
- Data Management Team Leader
- Clinical Data Manager
- Disciplined Work Approach
- Problem Solving
- Attention to Detail
- Computer Skills
- It is expected Knowledge of database structure, medical terminology and the drug development process and a minimum of 4 years’ relevant previous experience is required.
- Educated to University/College degree level or equivalent in a science or industry-related discipline
At Linical, we embrace the opportunities and possibilities that are held by diversity, equal opportunity and inclusion. We value bringing together individuals from diverse backgrounds regardless of race, disability, ethnicity, gender, sexual orientation or any other legally protected characteristic. Linical will consider all candidates that match with the requirements of the position, promoting diversity and equal opportunity for all.