Data Delivery Lead ID&V-Project GIFTS


The Pharmaceutical sector of Johnson & Johnson is now looking for Data Delivery Lead: At Janssen, part of Johnson & Johnson, Family of Companies, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information DATA DELIVERY LEAD – INFECTIOUS DISEASES AND VACCINES (GIFTs) Location: Leiden, Netherlands Full time permanent contract Role Overview The Data Delivery Lead (DDL) within the Integrated Data Analytics and Reporting (IDAR) organization formulates the Data Delivery strategy of one or more programs of medium to high complexity, within a disease area and/or therapeutic area. The DDL oversees the planning and execution of all data delivery activities across multiple clinical trials for the programs assigned. This position serves as the Data Delivery primary point of contact for the GCDO Program Leader (GPL). This position interfaces with the IDAR Liaison(s) to provide regular trial and/or program status updates and escalates Data Delivery issues to the IDAR Liaison(s), the functional leads within IDAR and the GCDO Program Leader (GPL) as needed.
The Associate Director level DDL provides leadership and expertise to the department in relevant technical areas and cross-functional initiatives with minimal guidance. This position provides input into the development of departmental policies, processes, training, and/or standards. Key Responsibilities:
  • Responsible for the planning, execution and completion of all Data Delivery (DD) activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned programs.
  • Serves as the Data Delivery (DD) primary point of contact to the GCDO GPL for each assigned trial/program. In collaboration with IDAR liaison, defines the Data Delivery strategy for the assigned programs.
  • Contributes to the development of DD vendor contracts and R&D Company business planning budget estimates.
  • Partners with the Operational Functional Leads (OFLs) to ensure proper resource allocation; evaluates resource demand in consultation with Portfolio Delivery and ensure updates to functional planning systems
  • Responsible for anticipation, prevention and early detection of issues impacting data delivery deliverables for a program. Manages program level data delivery issue resolution activities and escalates to IDAR liaison as needed.
  • Collaborates with third party 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 delivery related deliverables for co-development programs
  • Takes a leadership role for data delivery related aspects of regulatory agency inspections and J&J internal audits. Coordinates real time inspection readiness for all data delivery deliverables as necessary.
  • Provides leadership and strategic direction to Global Data Managers
  • Leads the Data Delivery team meeting for each program, as needed. Coaches and mentors Data Delivery team members and others as needed and provides input into development plans.
  • Leads departmental projects and implements solutions in collaboration with others. Actively identifies opportunities, evaluates and drives solutions to enhance efficiency and knowledge-sharing at the department level.
  • Takes a leadership role in cross-IDAR or cross-functional initiatives/process improvements.

Qualifications
  • BS/BA plus 8-10 years of experience with expert data management knowledge is required. University/college degree in a scientific discipline is preferred. An advanced degree (e.g., MS/MA) is preferred.
  • Project management experience is required, as well as TA experience and strong portfolio knowledge. A good understanding of data management practices (including tools and processes), dealing with customers, leading teams to successful outcomes, outsourcing and contract oversight, and presentations, negotiations and leading through influence are required.
  • Demonstrated strong written and/or communication skills. Demonstrated leadership and decision making skills. Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational & business challenges. 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.
  • ID&V knowledge is a plus.
  • Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
We Offer:
  • A challenging and a very interesting job in one of the biggest global pharmaceutical companies
  • An opportunity to make an impact with your actions
  • An opportunity to help others develop further and improve in their daily tasks
  • Possibilities for own further development and growth
  • Many opportunities to participate on different projects and drive Janssen’s growth further
  • Motivating remuneration and many employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.
Primary Location
Netherlands-South Holland-Leiden
Organization
Janssen Biologics (7266)
Job Function
Clinical Data Management
Requisition ID
1700182319W
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