Clinical Affairs Data Manager
Clinical Affairs Data Manager
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Salary Not Disclosed
1 Vacancy
Job Description
Benefits at bioMerieux:
Lowcost medical dental and vision benefits starting day one
11 paid holidays
160 hours of paid time off
Annual bonus
9.5 401k company contribution with no vesting period
Tuition reimbursement up to $10000 per calendar year
Onsite cafeteria with daily food stipend
Position Summary:
The Clinical Data Management Specialist contributes to clinical trials (CT) through leading Data Management (DM) activities such as : defining the entire data workflow building and maintaining clinical data bases training end users collecting handling and storing clinical trial data and ensuring their quality and integrity at a global level following applicable procedures and regulation. He/She works closely and independently with both internal and external clinical trials partners such as Clinical Scientists Biostatisticians and clinical sites personnel.
Main Accountabilities:
Lead and/or coordinate complex clinical trials as needed
- Attend CT kick off and is a key actor of the CA element team. Provides data management inputs for CT protocol writing.
- Initiate data management activities for each project : share proposal for future data bases design highlight issues and specific needs. Ensure that timelines for data management activities is appropriate for CT.
- Build and maintain data bases based on the requirements from CT protocol. Follow appropriate procedures to ensure that data bases are well validated and meet CT needs.
- Complete the monitoring plan with CS and Biostatisticians based on the monitoring strategy. Develop programs customized reports or equivalent to cover monitoring needs along the CT.
- Train data bases end users : prepare the training support and ensure the training is delivered accordingly before CT start. Ensure good traceability for the training.
- Manage data reviews and queries along the CT. Prepare and communicate reporting for CA element team members based on monitoring strategy. Including performing intermediate analyses as needed.
- Organize closure activities linked to data management following applicable procedures and prepare data bases for future analysis as needed. Develop and update data management training modules. Train CA new arrivals at a global level.
- Contribute to develop trainee(s) and apprentice(s) in Data Management.
- Assist Management for continuous improvement initiatives and special projects. Translate tools enhancements new processes in operational guidelines and training support and train end users accordingly. Ensure followup/maintenance for each enhancement. Share with key partners such as CS Biomaths.
StudiesExperience:
- Bachelors Degree required preferably in Data Management/Bioinformatics or equivalent with a minimum of 3yearspost degree relevant work experience preferred.
Skills and Qualifications:
- Analytical thinking/flexibility team work technical problem solving ability to explain quality focus good communication skills.
- Knowledge of Electronic Data Capture (EDC system) programming language (e.g. SAS) Pack Office is needed.
- Knowledge of Relational data bases including knowledge of SQL language Cloud solution Tableau and Python is a plus.
- Ability to Train and educate
- Excellent communication ability both written & verbal
- Excellent organization skills.
Required Experience:
Manager
Employment Type
Full Time
