Global Data Manager Specialist
Locations: Beerse, Belgium
Functions: Clinical Data Management
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Requisition ID: 1905740984W
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world and employs more than 4,000 professionals in Belgium. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
The GDM Specialist will be responsible to take a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). With the trial customer, CRO and other functional partners the GDM establishes conventions and quality expectations for clinical data and sets timelines and follow-up regularly to ensure delivery of all Data Management milestones.
The GDM will ensure compliance with Standard Operating Procedures (SOPs), policies and regulatory requirements from trial start-up through data-base lock and trial close-out. Represent functional area(s) in divisional/company-wide process initiatives.
Principal responsibilities will include:
* Ensures trial level oversight controls are performed as described in the oversight plan, Quality
Control (QC) process and work instructions with minimal Data Delivery Lead (DDL) direction.
* Ensures that clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
* Oversees the assessment of real-time inspection readiness of all Data Delivery (DD) deliverables for the trial; Participate in Regulatory Agency and J&J internal audits asnecessary.
* Leads the planning and tracking of content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
* Takes a leadership role with the assigned clinical working group(s) to ensure thatDD and TA trial needs and deliverables are met.
* Takes a leadership role to obtain and share best practices with internal partners.
* Leads others in implementing process, system, and tool improvement initiatives within DD.
* Presents and trains at investigator andmonitor meetings.
* A minimum of a BS/BA degree or professional experience equivalent.
* Minimum 5 years Clinical Data Management experience.
* Experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
* Electronic Data Capture (Medidata RAVE, Inform) platforms preferred
* Experience in clinical drug development within the pharmaceutical industry or related industry.
* SAS experience desired
* Vendor oversight experience required.
* Team leadership experience required.
* Project management experience required
What's in it for you…?
"Caring for the world, one person at a time…"
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management