At Janssen, 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, 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 (J&J). Please visit http://www.janssen.co.uk/ for more information
We are recruiting for an Associate Director Data Management Leader, located in High Wycombe, UK.
The Data Management Leader (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 coordinates 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, mentoring and performance management responsibilities. This position identifies assignments for flex staff and assesses efficiency 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 raises 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 leads to develop IDAR strategies for an assigned program.
The Sr. Manager level DML provides leadership and expertise to the department in relevant technical areas and cross-functional initiatives, departmental policies, processes, training, and/or standards.
- Responsible for the planning, execution and completion of data management (DM) activities on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned programs/regions.
- Serving as the DM primary point of contact to the GCDO GPL for each assigned trial/program/regions. In collaboration with IDAR TAL and TA FL, defines the DM strategy including the choice of external service provider for the assigned programs.
- Leads data management vendor contracts and R&D Company business planning budget estimates.
- Evaluating resource demand and ensures updates to functional planning systems
- Responsible for anticipation, prevention and early detection of issues impacting deliverables for a program/region. With minimal help, leads program/region level data management issue resolution activities and brings up to GPL, IDAR TAL, and TA FL as needed.
- Collaborating with IDAR staff and vendors to monitor work and ensure delivery of achievements that meet pre-defined expectations.
- Collaborating with internal cross-functional colleagues and external partners to define the data integration strategy for a program as appropriate.
- Collaborating with external partners on DM deliverables for co-development programs
- Taking a leadership role for DM aspects of regulatory agency inspections and J&J internal audits. Coordinates real time inspection readiness.
- Provides leadership by attracting and retaining top talent, developing team members and ensuring organizational efficiency, clarity and communication.
- 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.
- Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.
- Provides input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model. Performs interviews and proposes hiring decisions.
Do you have the skills and experience we are looking for?
- BSc / MSc with and 5+ yrs relevant experience OR PhD with post-doc experience with 3+ yrs.
- In-depth knowledge of data management practices (including tools and processes) and regulatory guidelines is required.
- TA experience and strong portfolio knowledge
- Project management experience partnering with customers, leading teams to successful outcomes, outsourcing strategies, contract oversight, negotiations and leading through influencing.
- Proven strong interpersonal skills. Excellent leadership, decision-making skills and proven ability to develop team efficiency and cohesiveness, act as a change agent, and adapt to rapidly changing organization and business environment. Proven innovative thinking to allow for efficient 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.
- Experience working on cross-functional teams is required.
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.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)
Clinical Data Management