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 Senior Global Data Manager 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 Senior Global Data Manager 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.
- Performs trial level oversight controls as described in the oversight plan, Quality Control (QC) process and work instructions with minimal Data Management Lead (DML) 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 and monitor meetings