Analyst I, Global Data Manager

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Purpose

The Analyst Data Manager is a professional individual contributor role at entry level that provides oversight and accountability, executes data management activities and may perform scientific data review for one or more trials of low to moderate complexity. The Analyst Data Manager makes recommendations and influences decisions for specific trials or assignments. This position analyzes and provides input into decisions with direction from manager or Data Management Leader. This position receives ongoing direction to achieve objectives, and work is reviewed on a regular basis with the Data Management Leader.

Responsibilities

• Working with external suppliers, trial customers, and internal and external partners to establish, align, and confirm clinical data management expectations for assigned trial(s).
• Gathering and/or reviewing content and integration requirements for eCRFs and other data collection tools, and participating in the establishment of conventions, quality standards, and expectations for clinical data, datasets, and data structures.
• Collaborating with crossfunctional partners to set timelines, plan, track, and monitor data management milestones and deliverables, ensuring agreedupon content, format, quality, and ontime delivery with guidance from the Data Management Leader.
• Reviewing clinical data management documentation, including submission packages, to ensure appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency, and supporting compliance with regulatory guidelines and documentation requirements.
• Supporting realtime inspection readiness for assigned trials, including participating in regulatory agency inspections and J&J internal audits as required, in collaboration with the Data Management Leader.
• Supporting assigned clinical working groups to ensure data management and therapeutic area trial needs and deliverables are met.
• Identifying, documenting, and communicating triallevel lessons learned and frequently asked questions with support from the Data Management Leader.
• Contributing to the development of key functional plans (e.g., Integrated Review Plans), ensuring appropriate quality, scientific rigor, organization, accuracy, and consistency.
• Performing triallevel oversight activities and executing data management activities in accordance with applicable procedures, under the direction of the Data Management Leader.
• Participating in process, system, and tool improvement initiatives aligned with Global Data Management objectives.

Qualifications/Requirements

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences.
• Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols is preferred.
• Experience in clinical drug development within the pharmaceutical or related industry is preferred.
• Knowledge of applicable international guidelines regarding data management of clinical trials is preferred.
• Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) is preferred.
• Knowledge of technology platforms for data exchange and project management is preferred.
• Approx. <10% travel (domestic or international) may be required.

Preferred Skills

• Advanced Analytics
• Analytical Reasoning
• Biostatistics
• Business Behavior
• Clinical Data Management
• Clinical Operations
• Cross-Functional Collaboration
• Database Applications
• Data Privacy Standards
• Data Savvy
• Execution Focus
• Good Clinical Practice (GCP)
• Process Oriented
• Project Support
• Report Writing
• Standard Operating Procedure (SOP)

Compensation

The anticipated base pay range for this position is : $76,000.00 - $121,900.00

Additional Information on Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation -120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
• Holiday pay, including Floating Holidays -13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits