J&J Family of Companies Assoc. Director, Data Management, IDAR (1 of 3 openings) Leader in Spring House, Pennsylvania
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director Data Management Leader (1of 3 openings) Locations Belgium, Netherlands, UK, US.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management, and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.
The Data Management Leader (DML) – 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.
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 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.
Contributes to the development of data management vendor contracts and R&D Company business planning budget estimates.
Evaluates resource demand and ensures updates to functional planning systems.
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.
- 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 codevelopment 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.
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.
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.
Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.
Provides input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model. Performs interviews and proposes hiring decisions.
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.
May serve as a process, standard or system owner
May participate in or lead department or cross-department initiatives
Education and Experience Requirements:
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 required
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 required
In depth knowledge of regulatory guidance documents such as GCP / ICH requirements and relevant clinical R&D concepts required
Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
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.
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United States-Pennsylvania-Spring House-Welsh & McKean Roads
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Belgium
Janssen Research & Development, LLC (6084)
J&J Family of Companies
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