Title:  Clinical Operations Manager

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Join us in PUTNEY as CLINICAL OPERATIONS  MANAGER

Job Summary: 

We are looking for a dynamic and highly skilled Clinical Operations Manager to join our team. The development of novel products within Japan Tobacco International (JTI) requires the company to undertake international clinical studies as part of scientific and regulatory evaluations of user exposure to and uptake of nicotine. In addition, novel products need to be assessed for their potential to afford reduced-exposure / reduced-risk, and as such, an extensive clinical development program involving both clinical and human behavior investigations has been initiated.

You will be responsible for the oversight and the operational management of assigned clinical studies from protocol development to study close-out. The Clinical Operations Manager should ensure that studies are carried out according to the protocol, Standard Operating Procedures (SOPs), principles of Good Clinical Practice (GCP), and other applicable regulations.

What You’ll Do:

As Clinical Operations Manager, you will:

• Ensure the oversight and management of Contract Research Organization (CRO) and clinical vendors to safeguard the successful conduct of clinical trials and to ensure data integrity and quality
• Be responsible for managing studies from protocol development to close-out while overseeing Contract Research Organization (CRO) activities on assigned studies
• Contribute to essential study documents, coordinate reviews, and oversee audits and inspections
• Ensure optimal administrative/operational monitoring of clinical studies (including participation in feasibility assessments, site selection, and potentially co-monitoring, management of Investigator/study site interactions, etc.), review Clinical Research Associate (CRA) visit reports, and track site performance
• Maintain the Trial Master File (TMF) in strict compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP) and internal Standard Operating Procedures (SOPs)
• Manage study-related activities to meet Good Clinical Practice (GCP)/International Council for Harmonisation (ICH) guidelines
• Select and manage vendors (including Contract Research Organizations (CROs), laboratories)

The skills you'll need:

You as a Professional:

• You have a degree or PhD in Clinical Science or another appropriate Life Science or Health-related discipline
• You have 3+ years of experience in clinical trial execution in a tobacco, biotechnology (biotech), or pharmaceutical company or Contract Research Organization (CRO); A proven track record of managing a clinical trial from oversight of DM activities conducted by vendors, including eCRF development
• You have Contract Research Organization (CRO) and site management capabilities with a demonstrated ability to solve problems and mediate potential compliance issues
• You have an in-depth knowledge of Good Clinical Practice (GCP) guidelines and the clinical development process
• You have a full understanding of the scientific process and regulatory issues relating to human clinical and behavioral studies, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• You have experience in Contract Research Organization (CRO) selection and management, including drafting Requests for Proposals (RFPs) and managing the bidding process
• "Knowledge of clinical regulatory submission frameworks, including the European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Food and Drug Administration (FDA), and Pharmaceuticals and Medical Devices Agency (PMDA) is a plus, as is experience of submitting studies to and interacting with Ethics Committees"
• Experience in early and late-phase clinical studies is a plus
• You have proven experience managing projects cross-functionally

You as a person:

• You are fluent in English. A high standard of written English is mandatory. Other languages are a bonus
• You have great team spirit, can negotiate effectively, are self-motivated and driven and have strong communication skills
• You have excellent time management and organizational skills and have proven ability to work in a fast-paced, international, cross-functional environment
• You are dependable and focused on delivering high-quality outputs within tight deadlines
• You are comfortable working within a team or individually as required
• You enjoy working in a diverse people and culture environment and are happy to reach out to and collaborate with colleagues across the world

How we'll reward you:

In return, we offer a competitive salary of £75.000 - 85.000 per annum dependent on experience and a car allowance of £7,611 per annum. We’ll also provide you with a comprehensive benefits package that’s flexible to suit you and your lifestyle including a discretionary 20% bonus scheme and money to spend on a range of flexible benefits from share schemes to discounted gym memberships. 

It is important to us that you have a good work life balance so to encourage this we offer flexible working, working from home (50%) and 25 days holiday per annum which you can buy and sell to suit your needs. We know how important the future is, so we offer a very competitive non-contributory pension. For peace of mind for you and your family we also provide fully funded private medical insurance, life assurance, income protection and health screening.  

Inclusion 

At JTI, we want everyone to feel welcome, regardless of your background or needs. If you need adjustments making to your working environment, we’ll do everything we can to support you. As an employer, we are committed to promoting & protecting the physical and mental health of our employees.  

Next Steps 

Are you interested in applying? If so, please apply with your CV and a covering letter highlighting your suitability for the role.  

Are you ready to join us? Build your success story at JTI. Apply now!

Next Steps:

After applying, if selected, please anticipate the following within 1-3 weeks of the job posting closure: Phone screening with Talent Advisor > Assessment tests > Interviews > Offer. Each step is eliminatory and may vary by role type.

At JTI, we strive to create a diverse and inclusive work environment. As an equal-opportunity employer, we welcome applicants from all backgrounds. If you need any specific support, alternative formats, or have other access requirements, please let us know.