BE - Clinical Data Manager

The 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.

This is a long term contracting position!

Because of COVID-19, you will work from home full-time. After COVID-19, you are expected to be on-site (Diegem, Belgium) 3 - 4 days a week.

POSITION DUTIES & RESPONSIBILITIES:

• 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 Clinical Operations, Franchise and other BSDM functions for their respective projects.
• 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.

FUNCTIONAL AND TECHNICAL COMPETENCIES:

• 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), Medidata RAVE preferred.
• Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).

EDUCATION & EXPERIENCE REQUIREMENTS:

• A degree (or equivalent) in the biological sciences, Computer Science or related discipline, with at least 2 years of clinical data management experience in Medical Device or Pharmaceuticals
• Experience of supporting trials with minimal supervision.
• Flexibility with regard to working hours. As you will work closely with colleagues in the US, you have to take the hourly difference into account.

Note: This is a contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Ausy. Ausy can offer you a contract of indefinite duration, a project contract for the duration of the assignment at J&J or a freelance contract.