J&J Family of Companies Senior Global Data Manager in Beerse, Belgium
The GDM 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:
Performs trial level oversight controls as described in the oversight plan, Quality Control (QC) process and work instructions with minimal Data Delivery Lead (DDL) direction.
Reviews clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
Ensures real-time inspection readiness of all Data Delivery (DD) deliverables for the trial; Participate in Regulatory Agency and J&J internal audits as necessary.
Plans and tracks 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 that DD and TA trial needs and deliverables are met.
Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
Identifies and participates in 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.
Experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
Experience in clinical drug development within the pharmaceutical industry or related industry.
Vendor oversight experience is desired.
Team leadership experience is desired.
Project management experience is desired.
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management