Senior Global Data Manager

3 weeks ago

Mumbai, Maharashtra, India Johnson & Johnson Full time
Integrated Data Analytics and Reporting (IDAR)

Position Title*:
Senior Global Data Manager

Position Summary:

Type of Role:

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.

May be a member of more than one project of low to moderate complexity or member of one project of high complexity.


Impact of Decision-Making:
This position makes recommendations and influences decisions for specific trials or assignments. The Senior GDM influences processes, timing, and structure for specific trials or assignments.

Accountability/Decision-Making:
This position analyzes, provides recommendations, and makes decisions with direction from manager or DML.

Knowledge:
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. In-depth 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.

Supervision Received:
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.

Supervision Given:
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.

GDO Common Competencies:
Primarily at the Learning or Applying Level, see Appendix for competencies and proficiency levels.

DM Specific Competencies:
Primarily at the Learning or Applying Level, see Appendix for competencies and proficiency levels.

Principal Responsibilities:

  • 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).
  • With the trial customer, CRO and other functional partners:
o Gathers content and integration requirements for eCRF and other data collection tools.

o Establishes conventions and quality expectations for clinical data.

o Establishes expectations for dataset content and structure.

o Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.

  • Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
  • 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 DM 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 DM 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 DM.
  • Presents and trains at investigator and monitor meetings.
  • May undertake the principal responsibilities of a CDM, as appropriate.

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