Start-Up Local Trial 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 https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Support

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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Start-Up Local Trial Manager (SU- LTM) who will contribute to start-up activities for clinical trials in the UK.

The head office location is in High Wycombe, Buckinghamshire, UK, with a future move planned to Maidenhead in 2026.

This position is hybrid based.

Preferably the candidate will have experience across a number of therapeutic areas including  Haematology, Oncology & Immunology and expert knowledge of the ethical and regulatory requirements for study start up in the UK.

 

The SU- LTM will be the primary point of contact at a country level for start-up activities for assigned studies.

The SU- LTM is responsible for proactively coordinating the global and local trial teams to deliver quality trial documents as required to support the preparation and completion of study submissions in line with UK regulatory & ethical requirements.

The SU- LTM proactively contributes to process improvement, training and mentoring of other colleagues as needed.

Are you ready to join our team? Then please read further!

You will be responsible for:



* Preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions and essential document collection.


* Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorisations for study initiation.


* Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.


* Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.


* Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.



* Collaborating with the Global and Loc...