Johnson & Johnson Careers

Associate Director, Data Management Lead

Raritan, New Jersey; Spring House, Pennsylvania
Clinical Data Management


Job Description

Requisition ID: 6456180327

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, Data Management Lead within Global Clinical Development Operations.  This position will be in either Spring House, PA or Raritan, NJ and will require up to 10% travel.

 

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.


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. 


We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.


Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.  Proud to be an equal opportunity employer.


The Associate Director, Data Management Lead (DML) 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 oncology. The DML oversees the planning and execution of all data management activities across multiple clinical trials for the programs 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 GCDO Program Leader (GPL) and is accountable to the GPL for data management at the program 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 leads 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. 


Accountable for data management strategy, planning, execution of activities of medium to high complexity within one or more Oncology programs.

  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.
  2. Serves as the data management primary point of contact to the GCDO GPL for each assigned trial/program. 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. 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

Qualifications
  • A Master’s Degree and 8 years of relevant experience OR a PhD with Post-Doc and 5 years of experience is preferred
  • In-depth knowledge of data management practices (including tools and processes) and relevant regulatory guidelines is required
  • Therapeutic area 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
  • Experience working within a matrix environment is preferred
  • 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 is required
  • Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies is required
  • In depth knowledge of regulatory guidance documents such as GCP / ICH requirements and relevant clinical R&D concepts is required
  • This position will require you to be located in either Spring House, PA or Raritan NJ and will include up to 10% travel


Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Clinical Data Management
Requisition ID
6456180327