Clinical Trial Study Manager

WHO ARE WE: Doing now what patients need next. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

pRED CLINICAL OPERATIONS: Our North Star is to increase R&D Productivity and Patient Inclusivity. This is supported by our CO Strategy to deliver value for pRED CO and our portfolio. We aspire to be a leading edge Clinical Operations organisation that drives innovative patient-inclusive approaches in study design and execution, utilises advanced analytics to drive data-driven decisions, and embeds innovative technologies into our ways of working to improve productivity 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.

CONTRACT PURPOSE: As a contract Study Manager you will be assigned to pRED early phase clinical studies, and as part of a cross-functional study team, you will be responsible for delivering study management and clinical operations activities under the direction and leadership of a Study Management Team Leader. Through your direct study responsibilities you will also contribute to the management of external stakeholder relationships by helping Roche to be the preferred sponsor for sites, patients and other important healthcare providers.

WHAT YOU WILL DO / EXPECTATIONS DURING YOUR ASSIGNMENT: During your assignment you will participate as a member of the Study Management Team contributing to the delivery and execution of early phase study protocols. You will:

• DELIVER STUDY EXECUTION by providing operational expertise into protocol design and feasibility, country selection, patient centricity and data delivery plans in partnership with cross-functional stakeholders. Ensure study quality and integrity by developing and maintaining study systems and documentation (including informed consent forms, communication plan, Trial Monitoring Plan, Trial Master File etc).
• PROVIDE COUNTRY OVERSIGHT for insourced studies, by supporting or managing feasibility assessments to ensure countries and sites are selected for participation in studies. Provide guidance to country operational representatives during studies to ensure countries start-up on time and deliver on their recruitment commitments.
• MANAGE VENDOR PERFORMANCE by providing direction and actively managing relationships. Ensure vendors and third-party suppliers deliver against contracted scope of work and performance expectations and adhere to all appropriate standards (including ICH/GCP, SOPs and other regulations).
• PLAN DEMAND AND SUPPLY by overseeing the forecasting and maintenance of supplies (including IMP) needed to ensure sites have the necessary resources to run clinical studies.
• MANAGE RISK AND COMPLIANCE by assisting the study team in the identification, management and mitigation of study-related risks and issues in your areas of responsibility (including oversight of the risk, action and decision logs).
• DRIVE OPERATIONAL EXCELLENCE by providing operational expertise across a range of operations-related activities that drive improvement and consistency in the execution of clinical studies.

HOW YOU WILL DO IT: In Clinical Operations, mindset and behaviours are as important to us as skills and capabilities. You will succeed in the contractor Study Manager role by role modelling system thinking (connecting the bigger picture), agile behaviours (working flexibly, dealing with ambiguous situations, showing resilience), empowerment and accountability (using analytical thinking, tools, good judgement, and advice-seeking to make the right decisions), a growth mindset (fostering an exchange of ideas and experimentation) and creating value (helping to connect peers' work to a collective purpose).

WHO YOU ARE: You are talented and passionate. You are inspired by our mission and would fit in well with our collaborative, patient-centric and entrepreneurial spirit.

• Have a growth mindset and are excited about learning through experience.
• Feel comfortable thinking on your feet and thrive in fast-paced, ambiguous and highly collaborative environments.
• Hold a university degree or equivalent years of experience (preferred focus in life sciences).
• Have demonstrated strong and consistent performance as a Study Manager (or equivalent) in pharmaceutical and/or healthcare industry and drug development experience (therapeutic area experience a plus).
• A self-starter who finds passion in achieving successful outcomes and delivering excellence.
• Want to make a difference and find excitement in innovating practices and challenging convention.
• Possess strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines.

YOUR LOCATION: Welwyn (UK)

Who we are: A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

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.