ASSOC DIRECTOR DATA MANAGEMENT
The Data Management Leader (DML) – Associate Director within the Integrated Data Analytics andReporting (IDAR) organization proposes the Data Management strategy of one ormore 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 clinicaltrials for the programs/regions assigned.The DML supervises full time Global Data Managers (GDM) assigned to their programs and executesassociated hiring, onboarding, coaching and performance management responsibilities. Thisposition 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.
•Responsible for the planning, execution and completion of all data management activities ontime, within budget, and with high quality, consistent with departmental and company qualityand compliance standards for assigned programs/regions.•Serves as the data management primary point of contact to the GCDO GPL for each assignedtrial/program/regions. In collaboration with IDAR TAL and TA FL, defines the datamanagement strategy including the choice of external service provider for theassigned programs.•Evaluates resource demand and ensures updates to functional planning systems.•Responsible for anticipation, prevention and early detection of issues impacting datamanagement deliverables for a program/region. •Collaborates with IDAR staff and vendors to monitor work and ensure delivery of milestonesthat meet pre‐defined expectations.•Collaborates with internal cross‐functional colleagues and external partners to define thedata 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 agencyinspections and J&J internal audits. Coordinates real time inspection readiness for all datamanagement 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.•Provides supervisory support to direct reports, including coaching, mentoring, training, careerdevelopment, priority setting, etc.•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
Functional contacts within IDAR include, but are not limited to, Functional Lead, Global Data Managers(GDM), Clinical Data Acquisition Expert Leads, Statistical Programming Leaders, Clinical DataStandards, Risk Management Central Monitoring Leads, Regulatory Medical Writing Leads, IDAR TAL.Functional Contacts in Janssen (as collaborator or peer) include but are not limitedto GCDO Program Leaders, GCDO Trial Leaders, Biostatisticians, Clinical Teams – asneeded, Procurement, Finance, Regulatory, Clinical Project Management Leads, ExternalAlliances, Human Resources and Project Coordinators.Qualifications
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.
- 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.
- In depth knowledge of regulatory guidance documents such as GCP / ICH requirements and relevant clinical R&D concepts.
What is in it for you?
• Contributing to our mission to continue to bring transformational new medicines to patients for a world without disease.
• Being part of a motivated and experienced research team in an innovative working environment
• Through mentoring programs, e-university and on the job training, we ensure your personal development in a global company
• A competitive salary, on-site facilities, health/energy programs and other benefits for you and your family
• Flexible working hours, no fixed holiday planning, more than average amount of holidays and possibility to work at home (Home office is available upon approval from supervising manager in compliance with the local home office policy)Primary Location
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Brussels-Capital Region-Diegem, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-AllschwilOrganization
Janssen Pharmaceutica N.V. (7555)Job Function