Clinical Data Manager
The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned
projects with minimal supervision. S/he ensures 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,
- Have the ability to support a number of moderate complexity / complex trials with minimal supervision;
- Be 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;
- Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with the various stakeholders;
- Be responsible for participating 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;
- Be responsible for handling of non-CRF data, including lab data and image handling;
- Be 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;
- Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;
- Know and follow all regulations that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;
- Performs other related duties as required.
- A Bachelor’s degree (or equivalent) in the Biological sciences, Computer Science or related discipline.
- A minimum of 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 preferred
- 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).
- Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).
- An attractive salary in line with your experience and skills.
- Fringe benefits including a medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.
Evelien Van Eecke