Global Data Manager (1 of 10 positions) Job

Job description

Global Data Manager (1 of 10 positions)-1500064121WDescriptionAs Global Data Manager your role will involve gaining experience of all aspects of Global Clinical Data Management and certain relevant aspects of Clinical Research.
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 an Global Data Manager you have an opportunity to bring positive impact to patients health care and well being. You will utilize your scientific background and make an immediate contribution to the world of clinical trials.
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:
- Gathers content and integration requirements for electronic Case Report Form (eCRF) and other data collection tools.
- Participates in establishing conventions and quality expectations for clinical data.
- Participates in establishing expectations for dataset content and structure.
- 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 (including submission package) 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 IDS 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.
QualificationsEducation Experience:Minimum of a Master degree in a life science curriculum.
Recent college graduate (must be within 1 year of their graduation).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.
- Good organizational skills.
- Ability to work in a team environment and independently as needed.
- Project Management .
- Good interpersonal skills.
- Good problem solving and decision making .Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization: JANSSEN INFECTIOUS DISEASES-DIAGNOSTICS BVBA (7563)Job Function: Clinical Data Management