Clinical Trial Administrator

Clinical Trial Administrator

Location: Remote (Occasional travel to Leeds site if required). Must reside in UK

Duration: 12 months

Hours: 37 hours per week

Imagine your next project as a Clinical Study Administrator, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

The CSA is responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required and support project managers within the assigned clinical studies. This will involve: 

• Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, etc.

• Work with Study Teams and partners to maintain and track relevant activities in CTMS.

• Creation/distribution of regulatory binders 

• Timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.

• Distribution of safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).

• Creation and generation of system reports.

• Provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs

• Assist with Device tracking and ordering if required and if applicable.

Metrics/KPIs: 

• Metrics/KPIs governing these services are outlined in the QOP document.

Interfaces – Primary/Other:

• Primary interfaces: Provider Functional Manager, TMF Manager, TMF Associate, CTL, Study Teams, Site Managers, Transition Agents.

• Other Interfaces: clinical sites, if necessary.

how to succeed

You will have the ability to work on your own initiative, be proactive and have great communication skills. You will also bring: 

• Previous clinical research experience or a Clinical/medical background.

• Requires previous administrative support experience or equivalent for at least 1 year.

• Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point). 

• Minimum of a Bachelor’s Degree is preferred

details

This contract will run for 12 months. It’s a remote position which could occasionally require travel to the Leeds site if needed. This role is full time (37 hours per week). 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE and Umbrella options are available.

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.