Senior Manager Clinical Data Standards

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.

About Innovative Medicine: 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.

We are searching for the best talent for a Senior Manager Clinical Data Standards, within Integrated Data Analytics & Reporting (IDAR), to guide the execution of projects, programs, and processes that span multiple related areas in support of the organisation's overall Clinical Data Standards strategy. You will apply comprehensive knowledge of Clinical Data Standards to install best in class policies, procedures, and plans for the area, ensuring consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.

The role may be located in Beerse, Belgium; High Wycombe, United Kingdom; or Leiden, Netherlands (Hybrid / 3 days onsite per week).

You Will Be Responsible For:

• Acting independently to facilitate programs and innovative initiatives for the organisation to advance Clinical Data Standards solutions.
• Working to achieve operational, functional, and business targets with measurable impact on results for the Clinical Data Standards area.
• Developing processes to provide accurate, timely, and consistent clinical data standards to study teams.
• Leading the implementation of new technologies for development and implementation of clinical data standards.
• Guiding junior colleagues through consultation and mentoring in techniques and processes, and providing functional (matrix) supervision.
• Integrating Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.

Responsibilities:

The Data Delivery Standards Senior Manager is responsible for the development and maintenance of standard content supporting the data flow from collection to SDTM. Examples of standard content are:

• Controlled Terminology (CT)
• Study Data Tabulation Model (SDTM)
• 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 Senior 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 8 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming.
• Minimum 5 years SDTM experience essential!
• 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.
• Demonstrated leadership on cross-functional projects.
• Demonstrated leadership in decision making and problem solving.
• Excellent spoken and written English.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium/Netherlands - Requisition Number: R-013845; United Kingdom - Requisition Number: R-014851. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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.