Indien solliciteer direct u verwijst naar een ongeldig webadres, is de vacature waarschijnlijk inmiddels vervuld.
Attendeer FMF hierop
Senior Manager, Data Management Lead - Infectious Diseases and Vaccines
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Data Management Lead - Infectious Diseases and Vaccines. This position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Chesterbrook, PA; Beerse, Belgium; Leiden, Netherlands; Breda, Netherlands; High Wycombe, United Kingdom; or Allschwil (Basel), Switzerland.
Het bedrijf / The company
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. And 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, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.
De functie / The role
The Senior Manager, Data Management Lead (DML) - Infectious Diseases and Vaccines within the Integrated Data Analytics and Reporting (IDAR) organization will propose the Data Management strategy of one or more programs of low to medium complexity within a disease area, therapeutic area or region. Oversee the planning and execution of all data management activities across multiple clinical trials for the programs/regions assigned. Supervise full-time Global Data Managers (GDM) assigned to their programs and execute associated hiring, onboarding, coaching and performance management responsibilities. Identify assignments for flex staff and assess effectiveness of flex staff as appropriate.
This position will serve 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. Escalate data management issues and propose 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. Provide leadership and expertise to the department in relevant technical areas and cross-functional initiatives. Provide 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 one or more programs/regions.
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.
Serve 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, define the data management strategy, including the choice of external service provider for the assigned programs.
Contribute to the development of data management vendor contracts and R&D Company business planning budget estimates.
Evaluate resource demand and ensure updates to functional planning systems.
Anticipation, prevention and early detection of issues impacting data management deliverables for a program/region. Manage program/region level data management issue resolution activities and escalates to GPL, IDAR TAL, and TA FL as needed.
Collaborate with IDAR staff and vendors to monitor work and ensure delivery of milestones that meet predefined expectations.
Collaborate with internal crossfunctional colleagues and external partners to define the data integration strategy for a program as appropriate.
Collaborate with external partners on data management related deliverables for codevelopment programs.
Take a leadership role for data management related aspects of regulatory agency inspections and Johnson & Johnson internal audits. Coordinate real time inspection readiness for all data management deliverables, as necessary.
Lead the data management team meeting for each program, as needed.
Provide leadership by attracting and retaining top talent, developing team members and ensuring organizational effectiveness, transparency and communication.
Accountable for performance management, career development and salary administration for direct reports and will make decisions appropriate to this type of oversight and management.
Provide supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.
Provide input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model. Perform interviews and proposes hiring decisions.
Ensure staff compliance with department Standard Operating Procedures (SOPs), policies and regulatory guidance documents.
Contribute to the development and maintenance of departmental policies, procedures, training and standards.
May serve as a process, standard or system owner.
Het profiel / Your profile
A minimum of Bachelor’s degree is required, preferably in a Scientific discipline. Advanced degree (Master’s, PhD is preferred).
A minimum of 5 years of relevant data management experience within the Pharmaceutical, Contract Research Organization (CRO) or Biotech industries is required.
Knowledge of data management practices (including tools and processes) and relevant regulatory guidelines is required.
Knowledge of regulatory guidance documents, such as Good Clinical Practices (GCP)/International Council for Harmonization (ICH) requirements and relevant clinical R&D concepts is required.
Experience in the Infectious Diseases and Vaccines Therapeutic Area is required.
People management experience is preferred.
Experience working on crossfunctional teams required.
Project management experience is preferred.
Experience with outsourcing strategies preferred.
Experience with contract oversight is preferred.
Must have excellent verbal and written communication skills.
Must have strong leadership, decisionmaking and negotiating skills.
Must have the ability to foster team productivity and cohesiveness, act as a change agent, and adapt to a rapidly changing organization and business environment.
Must have the ability to demonstrate innovative thinking to allow for optimal design and execution of clinical development strategies.
The ability to collaborate with all levels of management and influence decisionmaking across a matrix environment is required.
This position will require up to 10% travel.
Tenslotte ..... / Finally ....
United States-New Jersey-Raritan-920 US Highway 202
Europe/Middle East/Africa-Switzerland-Basel-City-Basel, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Chesterbrook, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Research & Development, LLC (6084)