ANALYST I GLOBAL DATA MANAGER

Position Summary.
The Analyst Data Manager is a professional individual contributor role at entry level that provides oversight and accountability and/or executes data management activities and/or performs 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 (DML).
This position receives ongoing direction to achieve objectives, and work is reviewed on a regular basis with the Data Management Leader.
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.
o Gather and/or review content and integration requirements for eCRF and other data collection tools.
o Participate in establishing conventions and quality expectations for clinical data.
o Participate in establishing expectations for dataset content and structure.
o 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 J&J 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.
.
study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
Participate in process, system, and tool improvement initiatives.
This position may be specialized into the following roles based on business needs.
Global Data Manager (GDM), Clinical Data Manager (CDM) Global Data Manager role-specific responsibilities.
Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.
Clinical Data Manager role-specific responsibilities.
Support (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS, and Study Responsible Physician related queries in EDC system.
Involvement in other clinical data review activities (e.
., Coding, SAE reconciliation) is possible.
Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.
Principal Relationships.
Reports into people manager position within functional area (e.
., Data Management Leader).
Functional contacts within IDAR include but not limited to.
Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.
Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to.
Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources and Project Coordinators.
External contacts include but not limited to.
External partners and suppliers, CRO management and vendor liaisons, industry peers and working groups.
Qualifications Education and Experience Requirements.
Required Bachelor's degree (e.
., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences.
Ability to communicate effectively in English (written and verbal).
Preferred Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.
Experience in clinical drug development within the pharmaceutical or related industry.
Knowledge of applicable international guidelines regarding data management of clinical trials.
Knowledge of current industry standards (e.
., CDISC, SDTM, CDASH, etc.).
Knowledge of technology platforms for data exchange and project management.
Other.
Approx.