Johnson & Johnson Careers

Associate Director, Data Integrations

Spring House, Pennsylvania; Raritan, New Jersey; Titusville, New Jersey; Horsham, Pennsylvania; Malvern, Pennsylvania
Clinical Data Management


Job Description

Requisition ID: 9166180809

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Data Integrations.  This position can be located in Spring House, PA; Malvern, PA; Horsham, PA; Raritan, NJ or Titusville, NJ.  Local remote work locations may be considered.
 
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 Associate Director, Data Integrations will report to the Data Management (DM) Infrastructure Head and lead the overall group domain to guarantee support required by the Integrated Data Solutions (IDS) organization.  This position is accountable for the project management according to agreed upon timelines and quality expectations in support of the IDS department (or in support of the trial programs and IDS projects).  This individual will work with DM and Clinical Working Groups leading projects and tasks supporting DM Deliverables.
 
Principal Responsibilities:
  • Participate in or lead non-trial related projects within IDS or cross-functionally.
  • Provide assistance and support to the DM Infrastructure Head and mentor Domain Leads.
  • Impact processes, project timelines, priorities, budgets, resources and functionality of conducting clinical trials and clinical trial software.
  • Make decisions that impact personnel development and talent management for direct reports.
  • Analyze and provide rationale to recommend decisions with direction from the DM Infrastructure Head and the senior leadership team.  Keep area leaders informed of decisions and be accountable for recommendations and decisions made by direct reports.
  • Provide expert knowledge of multiple systems, industry guidelines and regulations, and best practices.
  • Manage all aspects of Human Resources for organization, including development, staffing, and talent management.  Provide expert knowledge of human resources and people development processes and practices.
  • Manage Domain Experts and Infrastructure team members as appropriate.  Mentor Domain Leads Level One.
  • Provide overall leadership to the organization, including objective setting and ongoing review and evaluation.  Lead the development and implementation of an overall strategy for a domain.
  • Accountable for all functions within the domain that they lead and oversee external vendors in this area.
  • Lead domain related projects, including requirements gathering, project plan with related domain experts and budget management.  Ensure quality deliverables as agreed upon with internal customers.
  • Take a leadership role with GPS, participate in contract definition for domain and oversee contract review and approval.
  • Oversee vendor relationships, implementation, and integration for domain.
  • Share domain scope and strategy with IDS Operations and Contractor Research Organizations (CROs).  Identify and communicate lessons learned, best practices and frequently asked questions at domain level.
  • Take a leadership role for process, system, and tool improvement initiatives within IDS.
  • Participates in or leads non-trials/non-program projects of medium to high complexity.
  • Provide oversight and guidance for audit and inspections for domain area.

Qualifications
  • A minimum of 12 years of experience working in the Pharmaceutical or Health Care industry is required.
  • A minimum of 6 years of experience managing and developing people is required.
  • Experience with Electronic Data Capture (EDC) or related systems required.
  • Experience with Medidata Rave is required.
  • Experience with Rave Safety Gateway is preferred.
  • Experience in Data Management is required.
  • Knowledge of the clinical trial process is preferred.
  • Knowledge of Global Clinical Practices (GCPs), International Conference on Harmonization (ICH), and 21 CFR Part 11 is required.
  • Project and functional management experience is required.
  • Experience leading large complex projects is required.
  • Experience with contract negotiations required.
  • Experience with working in a global environment is preferred.
  • Must have excellent verbal and written communication skills.
  • Must have excellent analytical problem-solving and decision-making skills.
  • Must have the ability to prioritize and manage multiple tasks.
  • 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% travel.
 
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Primary Location
United States-Pennsylvania-Spring House
Other Locations
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Malvern
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Data Management
Requisition ID
9166180809