Job Description

Description: Integrated Data Analytics and Reporting (IDAR)

Position Title: Global Data Manager Specialist

Work Location : Mumbai, Bangalore or Hyderabad (Hybrid work mode)

Position Summary:

- Type of Role: This is a professional individual contributor role that provides oversight and accountability for multiple low, moderate, and high complexity trials. May be a member of multiple projects of low, moderate, high complexity or a leader of projects of low to moderate complexity.

- Impact of Decision-Making: This position makes recommendations and decisions that have an impact on specific trials or assignments. The GDM Specialist makes decisions for processes, timing, and structure for trials and assignments. This position makes recommendations for processes, timing, structure, and resources at a program level.

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

- Knowledge: Expert knowledge of the protocol and current clinical drug development processes is required. This position needs knowledge of applicable international guidelines regarding clinical trials end to end. Relevant system / technical knowledge are needed. This position requires expert knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) and the therapeutic area. In-depth knowledge of project management and techniques and knowledge of team management principles 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 or the immediate manager as needed.

- Supervision Given: There are no direct reports for this position. This position collaborates with Vendor/CRO and GDM to achieve successful, cooperative partnerships. This position recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship. The GDM Specialist mentors and coaches GDMs and Senior GDMs on trial level responsibilities. May delegate work to GDMs and Senior GDMs.

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

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

Principal Responsibilities:

- Takes a leadership role with the CRO, the trial customer(s), GDM and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). Identifies and communicates ways to improve deliverables.

- With the trial customer, CRO, GDM, and other functional partners: Takes a leadership role to gather content and integration requirements for eCRF and other data collection tools. Leads conventions and quality expectations for clinical data. Leads expectations for dataset content and structure. Sets timeline and follow-up regularly to ensure delivery of all data management milestones.

- Ensures trial level oversight controls are performed as described in the oversight plan, QC process, and work instructions.

- Ensures that clinical data management documents are reviewed accurately (including submission package) to facilitate 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 DM deliverables for the trial. Participates in regulatory agency and J&J internal audits as necessary.

- 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 that DM and TA trial needs and deliverables are met. Collaborates with the DML to develop scope of work and identify needed resources. Works with Infrastructure Organization to ensure all deliverables are effectively completed.

- Takes a leadership role to obtain and share best practices with internal partners. Leads others in implementing process, system, and tool improvement initiatives within DM.

- Presents information and trains investigator and site monitors.

- May undertake the principal responsibilities of a CDM, as appropriate.

Principal Relationships:

Education and Experience Requirements:

Core Experience:

- BA/BS degree or professional experience equivalent

- Data management experience

- Experience in clinical drug development within the pharmaceutical industry or related industry

- Vendor oversight experience

- Team leadership experience

- Project management experience

Desired Experience:

- 2 years of experience in therapeutic area

- 3 years of experience as a Senior Global Data Manager

Potential Accelerator Opportunities:

- Be a mentor to a colleague for a specific subject matter expertise (e.g., contracts, budget, etc.).

- Lead a change in data management techniques and/or processes.

- Take a leadership role in designing consistency for an activity across a drug program (e.g., lab processing, protocol deviation handling, etc.).

- Take a leadership role in domain expertise across the global J&J organization and within the industry.

- Make presentations to colleagues and peers across the global J&J organization.

- Build networks that include peers and senior management across the J&J organization.

- Participate in an industry panel, organization, or user group to gain knowledge and implement as appropriate.

It is important that you are effective in achieving your current goals and objectives, prior to engaging in accelerator experiences

Other:

GLP Behaviors:

- Integrity & Credo-based Actions

- Results & Performance Driven

- Sense of Urgency

- Strategic Thinking

- Big Picture Orientation

- Intellectual Curiosity

- Prudent Risk Taking

- Organization & Talent Development

- Collaboration & Teaming

- Self-Awareness & Adaptability

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