At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Data Analytics & Computational Sciences **Job Sub** **Function:** Clinical Data Management **Job Category:** Professional **All Job Posting Locations:** BE009 Turnhoutseweg 30 **Job Description:** **Manager, Data Delivery Standards** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a **Manager, Data Delivery Standards** within Integrated Data Analytics & Reporting (IDAR), to be located **Beerse, Belgium / Hybrid (3 days per week onsite).** The Manager, Data Delivery Standards will ensure consistency of clinical data standards across clinical trials and in compliance with regulatory requirements. As an individual contributor and developing subject matter expert, you will take a collaborative leadership role with minimal supervision to consult on projects, programs, and processes that span multiple related areas in support of the organisation's overall Clinical Data Standards strategy. In this role you will apply in-depth knowledge of Clinical Data Standards to install best in class policies, procedures, and plans for the area. _Are you ready to join our team? Then please read further!_ **You will be responsible for:** + Acting as a top-level specialist to establish programs and innovative initiatives for the organisation to advance Clinical Data Standards initiatives + Managing standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements. + Participating in the development of processes to provide accurate, timely, and consistent clinical data standards to study teams. + Communicating ideas for process improvement, while assisting in developing and implementing new technologies for development and implementation of clinical data standards. + Coaching and training junior colleagues in clinical data standards techniques, processes, and responsibilities. + Integrating Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making. The Manager, Data Delivery Standards is responsible for the development and maintenance of standard content supporting the data flow from collection to SDTM. Examples of standard content are: + Study Data Tabulation Model (SDTM) including Controlled terminology and Dictionary maintenance + Annotated Case Report Forms (aCRFs) + Support Data Transfer Agreement (DTA) standards with SDTM + Mapping metadata from data collection (CRF and DTA) to SDTM. The Data Delivery Standards Manager is responsible for acquiring and maintaining deep expertise in the various data collection tools applied in the clinical trials such as DTAs, Clinical Data Tools such as LSAF and Pinnacle 21, and in CDISC standards such as STDM, CDASH, Controlled Terminology, and define.xml. **Principal Relationships:** **Internal:** Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Clinical Data Standards and others as needed. **External** Interact and collaborate with vendors. Act as J&J representative for defining process standards and sharing practices with industry counterparts and working groups, as required. **Education and Experience Requirements:** + A bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD) + At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming + Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM) + Demonstrated written and verbal communications skills + Demonstrated customer focus and solution-oriented experience + Demonstrated interpersonal skills to build relationships with internal and external business partners + Proven leadership on cross-functional projects + Proven leadership in decision making and problem solving + Excellent spoken and written English **Benefits:** We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. **\#LI-Hybrid**