Analyst, Global Data Manager (1 of 3)

6084-Janssen Research & Development Legal Entity • Titusville, PA

7d • Hybrid

About The Position

The Analyst, Global Data Manager (GDM) is a professional individual contributor role at entry level that will provide oversight and accountability and/or execute data management activities and/or perform scientific data review for one or more trials of low to moderate complexity. The Analyst, GDM will make recommendations and influence decisions for specific trials or assignments. This individual will analyze and provide input into decisions with direction from a manager or Data Management Leader (DML). This position receives ongoing direction to achieve objectives, and work is reviewed on a regular basis with the DML.

Requirements

• A minimum of a Bachelor's degree is required, preferably in Clinical Data Management, Life Sciences or Computer Sciences.
• Must have excellent verbal and written communication skills.
• Must have the ability to adapt to a rapidly changing organization and business environment.

Nice To Haves

• Clinical data management experience is preferred.
• Knowledge of scientific concepts presented in clinical trial protocols is preferred.
• Experience in clinical drug development within the pharmaceutical industry, Contract Research Organization (CRO) 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., Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), Clinical Data Acquisition Standards Harmonization (CDASH), etc.) is preferred.
• Knowledge of technology platforms for data exchange and project management is preferred.
• The ability to collaborate with all levels of management in a cross-functional team environment is preferred.

Responsibilities

• Work with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s).
• Gather and/or review content and integration requirements for Electronic Code of Federal Regulations (eCFR) and other data collection tools.
• Participate in establishing conventions and quality expectations for clinical data.
• Participate in establishing expectations for dataset content and structure.
• Work with others to set timelines and follow-up regularly to monitor delivery of all data management milestones.
• Review clinical data management documents (including submission package) for appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Work with DML to facilitate compliance with regulatory guidelines and the documentation matrix.
• Work with DML to facilitate real-time inspection readiness of all assigned deliverables for the trial.
• Participate in regulatory agency inspections and Johnson & Johnson internal audits as necessary.
• Work with DML to plan and track content, format, quality, and timing of applicable data management deliverables.
• Work with DML to ensure deliverables are on time.
• Support the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are met.
• Identify and communicate lessons learned with support from DML and frequently asked questions at trial level.
• Contribute to the creation of key functional plans (e.g., study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Participate in process, system, and tool improvement initiatives.
• Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level