Clinical Trial Study Manager (1 Year FTC) in Welwyn

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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.

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.

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.

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).

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 should 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).
• 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.
• A desire to make a difference and find excitement in innovating practices and challenging convention.
• Strong working knowledge of drug development process and respective regulations, including ICH and GCP guidelines.

Your location: Welwyn (UK)

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.