Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Global Data Manager. This position can be located in Raritan, NJ; Titusville, NJ; or Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Senior Global Data Manager will provide oversight and accountability for more than one low to moderate complexity trial or one high complexity trial. This individual may be a member of more than one project of low to moderate complexity or member of one project of high complexity.
Make recommendations and influence decisions for specific trials or assignments. Influence processes, timing, and structure for specific trials or assignments.
Analyze, provide recommendations, and makes decisions with direction from manager or Data Management Lead (DML).
Collaborate with Vendors/Contract Research Organizations (CROs) to achieve successful, cooperative partnerships.
May delegate tasks and assignments to Global Data Managers (GDMs).
Takes leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). Gather content and integration requirements for electronic Contract Request Form (eCRF) and other data collection tools. Establish conventions and quality expectations for clinical data. Establish expectations for dataset content and structure. Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
Perform trial level oversight controls as described in the oversight plan, Quality Control (QC) process and work instructions with minimal DML direction.
Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
Ensure real-time inspection readiness of all Integrated Data Services (IDS) deliverables for the trial. Participate in Regulatory Agency and Johnson & Johnson internal audits as necessary.
Plan and track 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. Ensure deliverables are on time.
Take a leadership role with the assigned clinical working group(s) to ensure that IDS and Therapeutic Area (TA) trial needs and deliverables are met.
Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
Identify and participate in process, system, and tool improvement initiatives within IDS.
- Present and train at investigator and monitor meetings.
A minimum of 5 years of data management experience is required.
Experience within the Pharmaceutical, Contract Research Organization (CRO) and/or Biotech industry is preferred.
- Vendor oversight experience is preferred.
- Experience with data validation is required.
Experience with data standardization is preferred.
Knowledge of how data flows within the clinical trial process is preferred.
Experience with User Acceptance Testing (UAT) is preferred.
Experience with Electronic Data Capture (EDC) (i.e. Medidata Rave, InForm, etc.) is preferred.
Experience with Artificial Intelligence is preferred.
Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is preferred.
- Project management experience is preferred.
Strong leadership skills (i.e. mentoring, training, etc.) preferred.
Experience with working in a global environment is preferred.
Must have excellent communication and presentation skills
Must have the ability to think analytically, be quality results oriented and customer focused.
The ability to collaborate and build relationships with internal and external partners in a cross-functional environment is required.
This position will require up to 10% domestic and international travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)
Clinical Data Management