To assist and learn the role of Study Leaders and Study Associates in the following activities:
Provides logistical support to a multi-disciplinary team which meets regularly with the aim to oversee early phase study activities across a range of disease therapeutic areas
Develop, maintain and manage appropriate study documentation
Collects and reviews regulatory documents from clinical sites
Initiates, maintains and reconciles Trial Master File in accordance with SOP requirements
Organises and maintains tracking systems and tools to support the clinical study from planning through to post close-out activities.
Maintains accurate tracking and reporting of study metrics
Coordinates communication of tracking information within a multidisciplinary team and to the sites
Manages and tracks clinical / non-clinical supplies
Manages and tracks study-specific payments
Coordinates investigator and/or monitor meeting planning, including preparing meeting materials and on-site meeting implementation. May present at investigator meetings
Organises the logistics of the service providers kick off meetings and any subsequent face to face meetings in collaboration with the Study Leaders. Participates as required in vendor meetings.
Collaborates with Study Leaders on the development of certain study-specific plans and/or processes
May support the Operations Alliances group with non-study specific activities related to remit of the group
May support departmental initiatives.
Roche In The UK
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 are Roche.
We require support within the global Biosample Operations function in a variety of biosample management activities, similar to but not limited to:
Supports and assists in day to day biosample operational activities that support the Biosample Operations Specialists with their clinical projects and studies.
Support in the development, maintenance and management of appropriate biosample management documentation.
Coordinate communications to both internal and external stakeholders.
Supports in the organisation of central lab meetings and any subsequent face to face meetings in collaboration with the Biosample Operations Specialists.
Participates as required in stakeholder and vendor meetings.
Assists the Biosample Operations Specialist with study specific financial management.
Participates in the review and oversight of the clinical project and study biosample specific metrics.
Collaborates with the Biosample Operations Specialist on innovative and functional initiatives.
Oversees the maintenance and application of different internal tools and platforms that support biosample management activities and the biosample operations team.
Business Operations Management
Working with a wide range of functions in Business Operations Management (BOM) to provide essential support through early phase clinical trials (which includes Quality, Resource Management & Analytics, Continuous Improvement Projects, Process & Knowledge Management, Tools/Systems and Partnership Management)
Process modelling and maintenance to support our pRED Business Processes
Development of change management activities, communication channels and training material as needed Working with our Quality group, you will support the oversight of Clinical Research Organisations (CRO) by reviewing
monthly CRO Metrics
Data analytics: Using specialised data modelling tools, excel programming and other systems to explore data and support decision making
Supporting the assessment (and where applicable) implementation of innovative tools to optimise the delivery of our Clinical Trials
Support Initiatives driven within our BOM team by developed of material and key activities during the life of the project.
An ongoing university education in a scientific degree is required for clinical study and biosample operations. For the business operations role, a degree course in a more technical IT field will be considered.
You will have strong planning and organisational skills and the ability to manage multiple priorities at the same time. You will have good communication skills and be collaborative. Candidates must also be professional, reliable, team-orientated and friendly.
If you feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.