J&J Family of Companies Global Data Manager - Data Management Academy in Beerse, Belgium
You will be part of an intensive training and development program and with selected mentoring.
You will have the opportunity to develop the skills necessary to perform in the role of a Global Data Manager. As a member of the Data Management Academy you have an opportunity to bring positive impact to patient health care and well-being. You will utilize your scientific background and make an immediate contribution to the world of clinical trials.
As Global Data Manager your role will involve gaining experience of all aspects of Global Clinical Data Management and certain relevant aspects of Clinical Research.
It is expected that in the Global Data Manager position, you will gain knowledge, skills and experience required for the job through comprehensive training under guidance of experienced personnel and will be involved in the following activities:
Works with Contract Research Organization (CRO), the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned clinical trial(s).
With the trial customer, CRO and other functional partners:
Participates in establishing conventions and quality expectations for clinical data.
Works with others to set timelines and follows-up regularly to monitor delivery of all data management milestones.
Performs trial level oversight controls as described in the oversight plan, quality control (QC) process, and work instructions.
Reviews clinical data management documents for appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Works with team to facilitate compliance with regulatory guidelines and the documentation matrix.
Works with team to facilitate real-time inspection readiness of all Data Delivery deliverables for the trial. Participates in regulatory agency inspections and J&J internal audits as necessary.
Works with team to plan and track content, format, quality, and timing of data management deliverables, including, but not limited to eCRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Works with team to ensure deliverables are on time.
Supports the assigned clinical working group(s) to ensure that trial needs and deliverables are met.
Identifies and communicates lessons learned with support from team lead.
Participates in process, system and tool improvement initiatives.
Presents at investigator and monitor meetings.
Minimum of a Master degree in a life science curriculum.
Recent college graduate or PhD, but we’re also open for candidates with working experience.
Knowledge, Skills and Abilities that will be used and/or developed:
Ability to effectively apply knowledge and skills in a complex environment.
Good English written and verbal communication.
Good leadership skills.
Good organizational skills.
Ability to work in a team environment and independently as needed.
Good interpersonal skills.
Good problem solving and decision making.
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management