Johnson & Johnson Careers
Data Management Lead – Senior Manager
Requisition ID: 1700169401W
Global Clinical Development Operations (GCDO)
Integrated Data Analytics and Reporting (IDAR)
The Data Delivery Lead (DDL) - Senior Manager within the Integrated Data Analytics and Reporting (IDAR) organization formulates the Data Management Delivery strategy and is accountable and responsible for approximately 8-15 Medical Affairs studies across all therapeutic areas of low to medium complexity, within the Asia Pacific region. The DDL oversees the planning and execution of all data management activities across multiple clinical trials for the Asia Pacific Region. The candidate for this position must be able to work across time zones.
This position serves as the Data Management primary point of contact for the GCDO Medical Affairs Clinical Program Leaders (CPL) and is accountable to the CPLs for data management deliverables for the assigned Medical Affairs studies.This position escalates Data Management issues to Medical Affairs Functional Lead within IDAR and the GCDO Medical Affairs Clinical Program Leader (CPL) 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 Management strategy, planning, execution of activities of low to medium complexity within the Asia Pacific region for Medical Affairs studies.
- Responsible for the planning, execution and completion of all Data Management 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 Management primary point of contact to the GCDO Clinical Program Lead for each assigned Medical Affairs trial in the Asia Pacific region. In collaboration with IDAR Medical Affairs Functional Lead, defines the Data Management strategy including the choice of external service provider for the assigned programs.
- Contributes to the development of Data Management 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 the IDAR Medical Affairs Functional Lead and Portfolio Delivery and ensure updates to functional planning systems
- Responsible for anticipation, prevention and early detection of issues impacting Data Management deliverables for the Asia Pacific region. Manages the Asia Pacific region level Data Management issue resolution activities and escalates to IDAR Medical Affairs Functional Lead 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 Management related deliverables for co-development programs
- Takes a leadership role for Data Management related aspects of regulatory agency inspections and J&J internal audits. Coordinates real time inspection readiness for all data management deliverables as necessary.
- Provides leadership and strategic direction to Global Data Managers, including consistency at a program/region level from a data management perspective.
- Leads the Data Management team meeting for each program, as needed. Coaches and mentors Data Management 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.
This position reports to the Data Delivery and Analysis Functional Lead and has no direct reports. This position executes work independently and proactively suggests and receives assignments from the IDAR Medical Affairs Functional Lead. Status of work is self-managed and discussed at major milestones with the IDAR Medical Affairs Functional Lead, and within the GCDO program team, where issues possibly impacting program timelines and quality are discussed. This position may also be accountable to another DDDA Leadership team representative or DDDA Functional Lead, based on cross-DDDA or cross-IDAR project leadership assignment(s).
Functional contacts within IDAR include, but are not limited to IDAR Liaison, Functional Lead, Operational Functional Leads, Global Data Managers (GDM), Data Analysis Leads, IDAR Capabilities, Risk Management Central Monitoring Leads, Regulatory Medical Writing Leads, Value Stream Leads, Data Delivery and Data Analysis Head.
Functional Contacts in the organization (as collaborator or peer) include but are not limited to GCDO Global Program Leads, GCDO Global Trial Leads, Clinical Teams – as needed, Janssen Research Procurement, Finance, Regulatory, Clinical Project Management Leads, External Alliances, and Project Coordinators.
Contacts outside of the organization include but are not limited to, external partners, CRO management and vendor liaisons.
EDUCATION AND EXPERIENCE REQUIREMENTS
- Bachelors degree and 6+ yrs relevant experience OR Masters/MBA and 4+ yrs; PhD with post-doc experience with 3+ yrs. University/college degree in a scientific discipline is preferred.
- In-depth knowledge of data management practices (including tools and processes) and relevant regulatory guidelines is required. TA experience and strong portfolio knowledge is required. 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 environment. Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies.
- In depth knowledge of regulatory guidance documents such as GCP / ICH requirements and relevant clinical R&D concepts.
- Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen-Cilag Netherlands (8345)
Clinical Research non-MD