Senior Manager Data Management Lead

Job Description Janssen Research & Development, L.L.C., a division of Johnson & Johnsons Family of Companies is recruiting for a Senior Manager Data Management Lead.

The position is located in Spring House, PA, Titusville, NJ, Raritan, NJ and Chesterbrook, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.

Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.

We bring together the best minds and pursue the most promising science.

We are Janssen.

We collaborate with the world for the health of everyone in it.

Learn more at www.janssen.com and follow us JanssenGlobal.

Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Position Summary: Senior Manager Data Management Lead, (DML) within the Integrated Data Analytics and Reporting (IDAR) organization proposes the data management strategy of one or more programs of low to medium complexity within a disease area, 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 GCDO 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 leads to develop IDAR strategies for a program.

The Senior Manager level DML provides leadership and expertise to the department in relevant technical areas and cross‐functional initiatives.

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 low to medium 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/region.

In collaboration with IDAR TAL and TA FL, defines the data management strategy including the choice of external service provide 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.

11.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.

12.

Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.

13.Provides input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model.

Performs interviews and proposes hiring decisions.

14.Ensures staff compliance with department SOPs, policies and regulatory guidance documents.

Contributes to the development and maintenance of departmental policies, procedures, training and standards.

15.

May serve as a process, standard or system owner.

Qualifications Education and Experience Requirements: Bachelors/Master’s degree and 8 years relevant experience in a Pharmaceutical, CRO or Biotech environment OR PhD with post‐doc experience with 3 years work experience is required.

University/college degree in a scientific discipline is preferred.

Prior work experience in the execution 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 is strongly preferred.

Experience working on cross‐ functional teams is required.

Experience supervising staff is preferred.

Strong communication skills (written & presentation) and experience working within a matrix environment.

Quality, 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.

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, required Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibilty 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