Senior Manager/Associate Director, Standards Management Expert

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:

Beerse, Antwerp, Belgium, Leiden, South Holland, Netherlands, Mumbai, India, PENJERLA, Telangana, India

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 Management Expert CRF) 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 Management Expert (CRF) 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 Beerse, Beligum; Leiden, Netherlands; or Mumbai/Hyderabad, India.

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-046105

United Kingdom -Requisition Number: R-048175

Belgium/Netherlands/India - Requisition Number: R-048177

Switzerland - Requisition Number: R-048179

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:

Senior Manager / Associate Director Standards Management Expert (CRF) is responsible for the development and maintenance of clear specifications for standard content across the data lifecycle, including data collection, review, delivery and analysis & reporting, aligned with protocol and medical writing requirements. Examples of standard content:

• Standard case report forms, including validation rules and integrations (e.g., JEISR, IxRS)
• Standard questionnaires, rating scales, and clinical outcome assessments
• Supportive documentation to guide and support the adoption of standards in clinical trials.

The role is responsible for acquiring and maintaining deep expertise in the various data collection, review and analysis tools and templates applied in the clinical trials, specifically those in use in J&J (e.g., Rave eDC, Stds4U), in industry standards, including but not limited to CDISC standards (SDTM, CDASH, Controlled Terminology, and ) and adjacent data standards (e.g., HL7 / FHIR, OHDSI/OMOP).

The role should be knowledgeable in using common clinical data tools such as Medidata Rave, LSAF, Pinnacle 21, or SAS. The position may also be involved in innovative projects requiring the learning of new tools and standards.

The role is responsible for remaining aware of the industry standards development and trends, and regulatory requirements, to support the development strategy and evolution of the J&J standards accordingly.

The position will maintain oversight of ongoing standards development work and projects they are accountable for. The position will give specific attention to the fit with the CDS standards strategy, interdependences between projects, prioritization of projects, and standards development work in CDS while assessing the organizational readiness in CDS and the IDAR functions to implement the solutions in an optimal way in the clinical studies.

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

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