Clinical Trial Study Manager; FTC)

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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.

We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.

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.

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.

• 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…