"Do you want to work as LEAD Clinical Data Manager for a highly recognized biostatistical and eClinical service provider in the field of clinical research? Do you have knowledge and experience in SAS programming and CDISC standards, also in SQL (asset)? Do you have at least 1 year of experience in coordinating clinical trials and you are fluent in English? Then we might have the job of your dream!"
Job Description
Our clients institute was founded in 1991. A highly recognized biostatistical and eClinical service provider in the field of clinical research. To support their growth, they are actively looking for an:
"Experienced Lead Clinical Data Manager".
You will be joining an international and multicultural company that includes over 20 different nationalities with English as working language. By joining a group of 10 highly skilled Lead Clinical Data Managers, in the Clinical Data Management team of over 40 people, the successful candidate will strengthen the experienced team in Ottignies, Belgium. As Experienced Lead Clinical Data Manager you will ensure that all output for the studies, such as the SAS database, are delivered on time with the highest quality.
Responsibilities
- Coordinate the activities of the other CDM teams (EDC Specialists, Programming Specialists, Cleaning specialists…) to ensure the project's schedule is respected.
- Produce and maintain key study related Clinical Data Management documentation.
- Ensure the CRF meets the data collection requirements of the study through a review of the protocol and other supporting documentation.
- Define and review edit-checks included in the Data Validation Plan in agreement with the sponsor.
- Ensure external data (Labs, SAEs, etc…) are transferred and reconciled with the clinical database.
- Perform database unblinding and lock activities in close collaboration with the sponsor, Project Manager, statistician and other parties.
- Develop Data Management standards (templates and processes).
- Communicate with the sponsor and other project collaborators about data management issues.
Requirements
- The successful candidate must have a university degree in science, biostatistics or a health-related field and at least 5 years of experience in a similar position.
- Knowledge and experience in SAS programming and CDISC standards.
- Excellent knowledge of English, both oral and written
- Good planning and analytical skills.
- Excellent communication skills.
- Ability to work under stress.
Benefits
- A balanced salary package based on your capabilities and experience, including meal vouchers.
- Full Time position ( 80% is negotiable )
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17265
