Clinical Trial Expert

The Position

In Roche's Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world's toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered & inspired to bring forward extraordinary life-changing innovation at speed.

In Clinical Operations, we aspire to be a leading edge organisation that drives innovative patient-centric approaches in study design and execution, utilises advanced analytics to drive data-driven decisions, and embeds innovative technologies into our ways of working to drive productivity and delivery of programs and studies. We strive to create a workplace where team members own their own development and learning and are empowered to create and innovate.

As part of the CO Expert Cluster the Clinical Trial Expert is accountable for a range of areas driving all phases in the execution of trial(s). The role will require enterprise wide interconnectivity, networking and monitoring of the internal and external environment. You'll be responsible for the delivery of operational portfolio activities in support of the Programme Management Cluster within timelines, budget, quality while contributing towards improving productivity and approaching study delivery from a patient centric mindset. You'll also be delivering strategic components within your area of expertise that improve productivity metrics of CO.

Your impact

You work with the study teams to deliver clinical studies according to the expected and specified quality standards, within timelines and budget by the following:

• Providing support to the Cluster and a multi-disciplinary team which meets regularly with the aim to oversee early phase study activities across a range of disease therapeutic areas.

• Supporting the implementation of system, tools, and reports required during study execution, including input into requests for proposal, authoring of documents and potentially site personnel training.

• Leading Study Teams during specific phases of the study and/or accountable for the full implementation of certain study types.

• Initiating, maintaining and reconciling Trial Master Files in accordance with SOP requirements.

• Supporting Service Provider management, in close collaboration with the Study Leaders, including logistics, meeting management, etc., as needed.

• Collaborating with Study Leaders and Clinical Trial Experts on the development of study-specific activities plans and/or processes.

• Supporting pRED Clinical Operations with activities to improve patient centricity and increase productivity in clinical trial execution; may also include participating in departmental initiatives.

Your profile

• You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, patient centric and entrepreneurial spirit.

• You have a growth mindset and are excited about learning through experience.

• You're comfortable thinking on your feet and thrive in fast paced, ambiguous and highly collaborative environments.

• Have experience in the pharmaceutical or healthcare industry and drug development experience (therapeutic area experience a plus)

• Hold a university degree or equivalent years of experience, preferred focus in life sciences.

• Find passion in achieving successful outcomes by leading, coaching & inspiring others.

• You want to make a difference and find excitement in innovating practices, therapeutics and processes.

• Experience in working across the clinical trial lifecycle with a solid understanding of the clinical trial environment, including ICH-GCP as well as the sequence and interdependencies of the clinical trial management.

• Experienced in the clinical trial management tools and systems and their interdependencies e.g. IxRS, eCOA, centralised endpoint review (images, ECG or else), digital biomarkers etc.

• A solid grounding in business performance improvement methodologies including project conceptualisation, situational analysis, solution design, implementation and continuous improvement.

• You have an ability to collaborate with a range of stakeholders in the implementation of the strategic direction for the respective early development clinical studies.

• Proven ability to contribute and/or lead specific areas of trial execution within the agreed upon timelines

• You also have strong interpersonal skills, written, communication and negotiations skills., as well as being a highly organised, detail-oriented problem solver.

Locations

This role is open in Welwyn Garden City, UK; Little Falls, NJ, USA; or Basel, Switzerland

Your application

Please only provide your current compelling CV and/or Cover Letter. We very much look forward to seeing your application!

Roche commits to recognising talent and aptitude. We prioritize encouraging and supporting our employees in their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career.

We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.

Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.