Senior Clinical Data Manager, Neurovascular
Location
Belgium
Posted
2 days ago
Salary
€3.7K - €5.9K / month
Seniority
Senior
Job Description
Senior Clinical Data Manager, Neurovascular
Johnson & Johnson
• responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. • ensure clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. • support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required; • responsible for creation of data management plans and other data management documentation as needed with minimal oversight; • monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines; • participate in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project; • proactively identify and address issues that may impact the quality of the data, deliverables or timelines; • responsible for handling of non-CRF data, including lab data and image handling; • responsible for co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed; • contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;
Job Requirements
- A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline.
- at least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.
- Experience of supporting trials with minimal supervision.
- Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.
- Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc).
- Strong verbal and written communication skills.
- Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.
- Experience with Electronic Data Capture (EDC), Medidata RAVE preferred.
- Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).
Benefits
- an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health
- service anniversary and recognition awards
- employees - and in some location’s eligible dependents - can participate in several insurance plans.
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