Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization.
Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements.
Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams.
Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards.
Coaches and trains junior colleagues in clinical data standards application and responsibilities.
Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.
Responsible for the development and maintenance of clear specifications for standard content across the data lifecycle, including data collection, delivery, analysis & reporting, aligned with program requirements and medical writing.

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.
Demonstrated leadership on cross-functional projects.
Demonstrated leadership in decision making and problem solving.
Excellent spoken and written English.
Ability to commute to one of the aforementioned office locations.

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.

Manager, Standards Management Expert – DAS, TFL

Key skills