Function
Data Analytics & Computational Sciences
Sub function
Clinical Data Management
Category
Senior Manager, Clinical Data Management (P8)
Location
High Wycombe / United Kingdom
Date posted
Jun 24 2025
Requisition number
R-014851
Work pattern
Hybrid Work
Description
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 DESCRIPTION:

Senior Manager Clinical Data Standards
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. Learn more at https://www.jnj.com/innovative-medicine
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).
Are you ready to join our team? Then please read further!

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 provides functional (matrix) supervision.
• Integrating Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.

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.

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 provides functional (matrix) supervision.
• Integrating Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making

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