Johnson & Johnson Careers
Senior Global Data Manager
Requisition ID: 0739181220
This is a professional individual contributor role that provides oversight and accountability for more than one low to moderate complexity trial or one high complexity trial within the oncology therapeutic area. May be a member of more than one project of low to moderate complexity or member of one project of high complexity. The Senior Data Manager will make recommendations and influence decisions for specific trials or assignments. The Senior GDM influences processes, timing, and structure for specific trials or assignments. In addition, they will analyze, provide recommendations, and makes decisions with direction from manager or DML.
This position requires In-depth knowledge of the protocol. In-depth knowledge of current clinical drug development processes is needed. In-depth knowledge of applicable international guidelines regarding data management of clinical trials is required. This position needs to understand relevant system/technical knowledge. Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) is required.
Knowledge of technology platforms, confidentiality for data exchange, and project management and techniques is required.
Work is received in broad terms. Work is reviewed during major deliverables. Amount of instruction is limited. Work is reviewed with the Data Manager Leaders as well as with the immediate manager.
There are no direct reports for this position. This position collaborates with Vendors/CROs to achieve successful, cooperative partnerships. This position may delegate tasks and assignments to Global Data Managers. The Senior GDM recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship.
- Takes 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).
- Gathers content and integration requirements for eCRF and other data collection tools.
- Will establishe conventions and quality expectations for clinical data.
- They will establish expectations for dataset content and structure.
- He/She Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
- They will perform trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
- They will reviews clinical data management documents (including submission package) 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 IDS 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 IDS 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 IDS.
- Presents and trains at investigator and monitor meetings.
- Master’s degree or 6 years of professional experience equivalent is required.
- Do you have Clinical Data management experience/Oncology.
- Experience in clinical drug development within the pharmaceutical industry.
- Vendor oversight experience is required.
- Team leadership experience is required.
- Project management experience is required.
United States-New Jersey-Raritan-
Janssen Research & Development, LLC. (6084)
Clinical Data Management