北京招聘

Position Summary:
The Data Management Leader (DML) – Sr. Manager 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 Global 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 Sr. 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 provider 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.
Version 2.0 dated 27APR2020(FINAL)
Job ID: 10001412 Job Code: Manager 1, Clinical Data Management, JOB SUBFUNCTION: Clinical Data
Management (PG30), Org chart title: DATA MANAGEMENT LEADER
Page 2 of 3
For Internal Use Only
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.
1. 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.
2. Provides supervisory support to direct reports, including coaching, mentoring, training, career development, priority setting, etc.
3. Provides input into departmental staffing and/or sourcing strategy and ongoing evaluation of staffing/sourcing model. Performs interviews and proposes hiring decisions.
4. Ensures staff compliance with department SOPs, policies and regulatory guidance documents.
Contributes to the development and maintenance of departmental policies, procedures, training and standards.
1. May serve as a process, standard or system owner
2. May participate in department or cross-department initiatives
Principal Relationships:
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 Data Standards, Risk Management Central Monitoring Leads, Regulatory Medical Writing Leads, IDAR TAL.
Functional Contacts in Janssen (as collaborator or peer) include but are not limited to Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams – as needed, Procurement, Finance, Regulatory, Clinical Project Management Leads, External Alliances, Human Resources and Project Coordinators.
Version 2.0 dated 27APR2020(FINAL)
Job ID: 10001412 Job Code: Manager 1, Clinical Data Management, JOB SUBFUNCTION: Clinical Data
Management (PG30), Org chart title: DATA MANAGEMENT LEADER
Page 3 of 3
For Internal Use Only
External contacts include but are not limited to, external technology partners, CRO management and vendor liaisons.
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. Project management experience dealing with customers, leading teams to successful outcomes, outsourcing strategies, contract oversight, negotiations and leading through influence are recommended. Experience working on cross-functional teams is required. Experience supervising staff is preferred.
Demonstrated strong communication skills and experience working within a matrix environment. 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. 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.
Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.

强生是全球具综合性、业务分布范围广的医疗保健企业，业务涉及消费品、制药、医疗器材三大领域，1985年在华创立了***家合资企业。强生遵循企业信条的价值观，致力于践行“关爱全世界,关注每个人”的健康愿景，以领先的科技研发创造创新的理念、产品和服务，为改善人类健康和福祉而不懈努力。每天，强生遍布世界各地的员工，与他们的合作方一起，为全球消费者和病患带来更健康、更快乐、更长寿的生活。
强生于1985年在华创立了***家合资企业。 多年来，强生不断发挥行业领军作用，以创新、高质量的产品和服务，为中国亿万家庭带来健康。如今，强生在中国的业务涉及消费品、制药、医疗器材三大领域，在北京、上海、广州、苏州、西安等90多个城市，拥有员工总数近10,000人。强生在西安高新技术产业开发区投资兴建先进的大型生产基地，以更好地服务中国和亚太地区其他国家。
强生是***在中国成功实现“端到端”研发模式的跨国企业；并通过实现从早期研发到临床应用，致力于加速中国创新产品的研发，促进中国创新型经济的发展。强生的三大业务领域在中国均设有研发机构, 并在上海建立了强生亚太创新中心，将源自于中国和亚太区域的创新成果推向国际市场。
该创新中心是强生深化外部合作战略的主要窗口。强生将密切与创新企业、学术和科研机构，以及优秀人才的合作，通过提供资金、专业知识和技术，共同将雏形创新转化为医学临床应用的成果，强生并在中国建立全球肺癌研究中心，以满足中国及国际市场的需求，造福病患。
强生心系中国的发展和进步，致力于成为优秀的企业公民。强生积极参与各类重大活动，助力中国的社会经济发展， 并荣幸的成为2008年北京奥运会及残奥会和2010年上海世博会美国馆的全球合作伙伴。
为加强对中国市场的承诺，强生于近期部署了中国发展新战略。强生将融汇全球的资源、凝聚在华的核心业务能力，更加稳健的迈开公司积极创新、完美执行和锐意领先的步伐，为中国创造更多价值。
强生多次荣获《巴伦周刊》“全球最受尊敬企业”的荣誉，充分体现了强生始终以实际行动改善人类健康福祉的不变理念。
2017年，强生连续第33年入选美国《财富》杂志发布的全球最受赞赏企业排行榜，位列总榜第13名，居全球制药行业榜首。