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Senior Manager, Data Delivery Lead
Requisition ID: 4504180226
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Manager, Data Delivery Lead located in Spring House, PA, Raritan, NJ, or Titusville, NJ.
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. We pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more.
The Data Delivery Lead (DDL) - Senior Manager within the Integrated Data Analytics and Reporting (IDAR) organization formulates the Data Delivery strategy of one or more programs of low to medium complexity, within a disease area and/or therapeutic area or region. The DDL oversees the planning and execution of all data delivery activities across multiple clinical trials for the programs/regions assigned.
This position serves as the Data Delivery primary point of contact for the GCDO Program Leader (GPL) and is accountable to the GPL for data delivery at the program/region level. This position interfaces with the IDAR Liaison(s) to provide regular trial and/or program status updates and escalates Data Delivery issues to the IDAR Liaison(s), the Functional Leads within IDAR and the GCDO Program Leader (GPL) as needed.
The Senior Manager level DDL provides
leadership and expertise to the department in relevant technical areas and
cross-functional initiatives with some guidance. This position provides input and/or leadership into the
development of departmental policies, processes, training, and/or standards.
Accountable for Data Delivery strategy, planning, execution of activities of low to medium complexity within one or more programs/regions.
- Responsible for the planning, execution and completion of all Data Delivery (DD) activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned programs/regions.
- Serves as the Data Delivery (DD) primary point of contact to the GCDO GPL for each assigned trial/program/region. In collaboration with IDAR liaison, defines the Data Delivery strategy including the choice of external service provider for the assigned programs.
- Contributes to the development of DD vendor contracts and R&D Company business planning budget estimates.
- Partners with the Operational Functional Leads (OFLs) to ensure proper resource allocation; evaluates resource demand in consultation with IDAR Liaison and Portfolio Delivery and ensure updates to functional planning systems
- Responsible for anticipation, prevention and early detection of issues impacting Data Delivery deliverables for a program/region. Manages program/region level Data Delivery issue resolution activities and escalates to IDAR liaison as needed.
- Collaborates with IDAR staff and vendors to monitor work and ensure delivery of milestones that meet pre-defined expectations.
- Collaborates with internal cross-functional colleagues and external partners to define the data integration strategy for a program as appropriate.
- Collaborates with external partners on Data Delivery related deliverables for co-development programs
- Takes a leadership role for Data Delivery related aspects of regulatory agency inspections and J&J internal audits. Coordinates real time inspection readiness for all data delivery deliverables as necessary.
- Provides leadership and strategic direction to Global Data Managers, including consistency at a program/region level from a data delivery perspective.
- Leads the Data Delivery team meeting for each program, as needed. Coaches and mentors Data Delivery team members and others as needed and provides input into development plans.
- May lead departmental projects and implements solutions in collaboration with others. Accountable for actively identifying opportunities, evaluates and drives solutions to enhance efficiency and knowledge-sharing at the department level. Stays current with industry trends that have an effect on departmental processes.
- Serves as a departmental resource in areas of technical expertise.
- Takes a leadership role in cross-IDAR or cross-functional initiatives/process improvements.
- Participates in project or trial initiation activities, as needed.
- A minimum of a Bachelor’s degree with 6 years of relevant experience OR a Masters/MBA and 4 years of relevant experience OR a PhD with post-doc experience and 3 years of relevant experience is required
- A college/University degree in a scientific discipline is preferred
- Experience in clinical drug development within the pharmaceutical industry or related industry is required
- In-depth knowledge of data management practices (including tools and processes) and relevant regulatory guidelines is required
- Oncology TA experience and strong portfolio knowledge is preferred
- Experience working in an early development phase is preferred
- Ability to take a leadership role in identifying ways to reduce budgetary costs is preferred
- Project management experience dealing with customers, leading teams to successful outcomes, outsourcing strategies, contract oversight, negotiations and leading through influence are required.
- Experience working on cross-functional teams is required.
- Demonstrated strong communication skills and experience working within a matrix environment.
- Excellent leadership, decision-making skills and proven ability to foster team productivity and cohesiveness, act as a change agent, and adapt to rapidly changing organization and business environments is required
- Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies is required
- Knowledge of Electronic Data Capture (Medidata Rave) platforms is preferred
- In depth knowledge of regulatory guidance documents such as GCP / ICH requirements and relevant clinical R&D concepts is required
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Clinical Data Management