Clinical Operations Lead (COL) Industrial Placement Student (IPS)

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

Who we are

Roche's Product Development organisation is dedicated to delivering outstanding therapies to patients. We conduct global clinical trials, analyse results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients.

Our vision is to be an inspirational world-leading Development organisation with the most talented people in the industry who make decisions based on science, patients and balancing time and risk. Our mission is to improve patients’ lives around the world with unique medicines that have meaningful impact.

In Product Development Clinical Operations (PDG), we aspire to be leaders in Clinical Operations, emphasizing the importance of speed and cost-effectiveness, while instilling an enterprise-wide perspective in all our work so that we continue to deliver for Patients and Roche.

Globally we are based at five headquarter sites: Basel, South San Francisco, Mississauga, Shanghai and Welwyn Garden City. Clinical Operations comprises of hundreds of people, who run phase I - IV clinical trials across a wide number of indications in Oncology, Haematology, Cardiovascular, Renal, Metabolism, Immunology, Infectious Diseases, Ophthalmology and Neuroscience. Individuals within these therapeutic areas are responsible for providing operational project management, leadership and expertise and act as the interface between Roche and external parties for optimal study delivery.

Note: This is not a laboratory- based role.

We partner with hospitals and other institutions to get new innovative medicines to patients in accordance with regulations and Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) standards, ensuring patient safety and that data collected from our patients is of a high quality.

As an Industrial Placement Student in Clinical Operations, you will get involved in supporting key tasks across a broad range of topics with potential to build your network outside of the department and ultimately helping accelerate drug development and successful execution of clinical trials.

We want you to join our mission and be part of our passionate, collaborative, evolving Clinical Operations community!

Position:

We are offering an outstanding opportunity for up to six Industrial Placement Students (IPS), who will be based in Welwyn Garden City, UK.

The IPS will sit within Clinical Operations and be assigned to a clinical trial as well as be part of a study and disease area community. The IPS will be included in working groups where they will have the opportunity to meet, work and collaborate with individuals in other functions outside of Operations, such as Clinical Science, Safety, Biometrics and Insights & Analytics to gain a broader understanding of roles in the Pharmaceutical industry.

The IPS will work closely with the Senior Clinical Operation Lead and Clinical Operation Leads, who are responsible for effective and efficient leadership and delivery of all operational components of a clinical trial across study start up, conduct and close-out in accordance with the appropriate quality standards including Good Clinical Practice (GCP) and applicable regulations.

Students may also have the opportunity to work with the Pharma Biosample Services group (PBS), providing support to PBS and the study teams during study close-out contributing to patients sample transfers to long term storage facilities for further exploratory research.

Key activities include:

• Clinical operations activities to ensure delivery during the lifecycle of phase I to IV studies
• Development and management of study timelines, risk and quality plans and the evaluation of study resource needs
• Providing day-to-day operational management to ensure delivery and the clinical trial runs smoothly; e.g. recruiting patients, problem solving, managing vendors/CRO’s (contract/clinical research organisations) and working with contracts.
• Working closely with our clinical research sites (hospitals) to help manage our clinical trial finances and invoicing
• Forecasting of clinical/non-clinical supplies
• Work within our safety team to process important adverse event reporting of trial subjects, and submit serious adverse reaction safety information to local ethics committees.
• You will help run reports and analysis to ensure adequate oversight of activities, such as trial master file maintenance, budget compliance and recruitment performance
• Working with PBS on Clinical Samples Long Term Storage request management activities at study closure
• Identifying areas of best practice, innovation and process improvements
• Ensuring study adherence to GCP and Standard Operations Procedures (SOPs)
• Attending/participating at Non study related activities, for example forums / departmental meetings / initiatives

About You

Applicants should be in the penultimate or last year of study, at the "Year in Industry” junction of their studies.

The placement is a full-time office-based role that requires your presence 5 days a week during the probationary period after which adaptable working will be assessed.

To be successful in this opportunity, applicants should also have:

• Excellent planning and organisational skills and the ability to manage multiple priorities at the same time
• Good communication and problem-solving skills.
• Professional, reliable, and team-orientated outlook
• Supportive and inclusive mindset, and be capable of demonstrating behaviours to work successfully in a collaborative working environment
• Awareness of your strengths and development areas
• A love of learning, shows up authentically, encourages growth and innovation and customer focused.
• Ability to come into the office for the majority of the time as well as being proficient in working in a virtual global setting when required.

Application Process

At Roche/Genentech, we believe our people are key to our success in bringing novel medicines to patients, and we are fully dedicated to being a great place to work and to providing the services, tools, and the environment where everybody feels empowered and trusted and is enabled to uncover their full potential. Join us and help build a diverse and inclusive organisation where patient centricity and patient access are our priority

Stage 1 : Our focus is to understand why you have applied for this role and what you will bring to the role to ensure team and personal success. Please provide:

• CV and a cover letter with your application. Your cover letter should not exceed one page.

Stage 2: F ollowing your application, you will be informed if you are successful and moved to the next stage of the process which will involve video questions / answers to support your application.

Stage 3: If successful at the Video Interview stage, you will be invited to the final stage of the application process. This will include a full day in person Assessment Center event at the Roche offices in Welwyn Garden City, further details will be provided if successful.

Ready to Apply?

The application window will be open until we receive enough applications to fill our cohort, after which we will close the programme to new applications.