Job Function: Data Analytics & Computational Sciences
Job Sub Function: Clinical Data Management
Job Category:Professional
All Job Posting Locations:Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:Johnson & Johnson Innovative Medicine R&D is recruiting for an Analyst, Global Data Manager. This position is a hybrid role and can be located in Spring House, PA; Horsham, PA; Raritan, NJ; or Titusville, NJ.
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.
Principal 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) to include but not limited to:
- 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.
Qualifications:
- A minimum of a Bachelor's degree is required, preferably in Clinical Data Management, Life Sciences or Computer Sciences.
- 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.
- Must have excellent verbal and written communication skills.
- Must have the ability to adapt to a rapidly changing organization and business environment.
- The ability to collaborate with all levels of management in a cross-functional team environment is preferred.
- This position will require up to 10% travel.
#LI-Hybrid
Required Skills: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)
The anticipated base pay range for this position is :$76,000.00 - $121,900.00
