Senior Manager

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

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

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

We are searching for the best talent for a Standards Technical Integration Lead within Integrated Data Analytics & Reporting (IDAR), to contribute to the Clinical Data Standards team as a leading expert individual contributor, guiding the execution of projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy.

Purpose:

The Standards Technical Integration Lead applies 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 Titusville, NJ / Raritan, NJ /Spring House, PA, US; High Wycombe, United Kingdom; Allschwil, Switzerland; Beerse, Belgium; Leiden, Netherlands; Hyderabad / Mumbai, India (Hybrid / 3 days onsite per week preferred).

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):

United States - Requisition Number: R-046101

United Kingdom -Requisition Number: R-048105

Switzerland - Requisition Number: R

Belgium/Netherlands/India - Requisition Number: R-048107

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:Job Description

Standards Technical Integration Lead is responsible for applying the strategy and tracking development of standards across the full data lifecycle from data collection through to submission, including standards for CRF, SDTM, ADaM, Reporting, CSR, etc. This may include adjacent data standards like FHIR and OMOP. This role will analyze requests, assess the impact across the lifecycle, and orchestrate changes across standards teams to deliver a holistic set of standards.

The position prepares trainings for trial teams on standards to ensure understanding and alignment across the full data lifecycle.

Standards Technical Integration Lead is positioned as a leader of the full standards process to ensure successful standards implementation.

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 best 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
• 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

#LI-Hybrid

Required Skills:

Preferred Skills:

Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Quality, Data Savvy, Good Clinical Practice (GCP), Innovation, Issue Escalation, Learning Management Systems (LMS), Leverages Information, Organizing, Program Management, Regulatory Affairs Management, Research Ethics, Technical Credibility

---