The Data Management Leader (DML) \xe2\x80\x93 Associate Director within the Integrated Data Analytics and Reporting (IDAR) organization proposes the Data Management strategy of one or more programs of medium to high complexity within a disease area and/or therapeutic area or region. The DML oversees the planning and execution of all data management activities across multiple clinical trials for the programs/regions assigned. The DML supervises full time Global Data Managers (GDM) assigned to their programs and executes associated hiring, onboarding, coaching and performance management responsibilities. This position identifies assignments for flex staff and assesses effectiveness of flex staff as appropriate. This position serves as the data management primary point of contact for the Global Program Leader (GPL) and is accountable to the GPL for data management at the program/region level. This position escalates data management issues and proposes solutions to the Functional Lead (FL), the GPL and IDAR Therapeutic Area Lead (TAL), as needed. The DML may work with the IDAR TAL and other IDAR leaders to develop IDAR strategies for a program. The Associate Director level DML provides leadership and expertise to the department in relevant technical areas and cross-functional initiatives with minimal guidance. This position provides input and/or leadership into the development of departmental policies, processes, training, and/or standards Principal Responsibilities: Accountable for data management strategy, planning, execution of activities of medium to high complexity within one or more programs/regions. 1. 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. 2. Serves as the data management primary point of contact to the GPL for each assigned trial/program/regions. In collaboration with IDAR TAL and TA FL, defines the data management strategy including the choice of external service provider for the assigned programs. 3. Contributes to the development of data management vendor contracts and R&D Company business planning budget estimates. 4. Evaluates resource demand and ensures updates to functional planning systems. 5. Responsible for anticipation, prevention and early detection of issues impacting data management deliverables for a program/region. With minimal guidance, manages. program/region level data management issue resolution activities and escalates to GPL, IDAR TAL, and TA FL as needed. 6. Collaborates with IDAR staff and vendors to monitor work and ensure delivery of milestones that meet pre-defined expectations. 7. Collaborates with internal cross-functional colleagues and external partners to define the data integration strategy for a program as appropriate. 8. Collaborates with external partners on data management related deliverables for co-development programs. 9. 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. 10. Leads the data management team meeting for each program, as needed. Provides leadership by attracting and retaining top talent, developing team members and ensuring organizational effectiveness, transparency and communication. 1. The individual is responsible for performance management, career development and salary administration for direct reports and will make decisions appropriate to this type of oversight and management. 2. Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc. 3. Provides input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model. Performs interviews and proposes hiring decisions. 4. Ensures staff compliance with department SOPs, policies and regulatory guidance documents. Contributes to or leads the development and maintenance of departmental policies, procedures, training and standards. 1. May serve as a process, standard or system owner 2. May participate in or lead department or cross-department initiatives Principal Relationships: Functional contacts within IDAR include, but are not limited to, Functional Lead, Global Data Managers (GDM), Clinical Data Acquisition Expert Leads, Statistical Programming Leaders, Clinical Data Standards, Risk Management Central Monitoring Leads, Regulatory Medical Writing Leads, IDAR TAL. Functional Contacts in Janssen (as collaborator or peer) include but are not limited to Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams \xe2\x80\x93 as needed, Procurement, Finance, Regulatory, Clinical Project Management Leads, External Alliances, Human Resources and Project Coordinators. External contacts include but are not limited to, external technology partners, CRO management and vendor liaisons

Qualifications

Bachelors/Masters degree and 5+ yrs relevant experience OR 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 recommended. Experience working on cross-functional teams is required. Experience supervising staff is preferred.
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\xe2\x80\x99s eligibility.