Early Phase Clinical Operations Industrial Placement
Roche
Welwyn,United Kingdom,
2h ago

Who we are

Roche Pharma Research & Early Development (pRED) translates world-class science into medical innovation through a diversity of technologies and talent located across seven research sites worldwide.

We deliver on individual patient needs through a deep understanding of disease biology and the implementation of Personalized Healthcare strategies

Our Clinical Operations organisation combines the core capabilities of Clinical Program Execution, Biosample Operations, and Business Operations Management (BOM) into one fully integrated unit focused on developing medicine for patients.

Clinical Program Execution works closely with Clinical Science to develop study protocols, set up and lead clinical studies in order to deliver high quality patient data to support the transition of investigational medicinal products into the late phase of the Roche organisation.

Biosample Operations bridges the science to operations by developing and executing the biosampling strategy for our investigational medicinal products.

Whilst putting patients at the forefront of everything we do, we leverage partnerships with, but not limited to, Science and external laboratories to transform quality biosamples into valuable data.

Business Operations Management is an integrated group of experts from resource management and analytics, to partnership management, knowledge management and learning, process and initiatives management, and quality performance excellence.

The BOM team enables platforms that ultimately supports Clinical Operations in the delivery of our clinical trial and clinical programs.

We are recruiting three Industrial Placement students within Clinical Operations, one for each of the three functions. You will play a key role in supporting key tasks across a broad range of topics, ultimately helping accelerate drug development and successful execution of clinical trials.

The Positions :

Clinical Program Execution

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
  • Organizes 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

  • Organizes 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
  • Biosample Operations

    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 organization 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 optimize 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
  • About You :

    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.

    Application Process :

    Stage 1 : CV & Cover Letter

    CV & Cover Letter

    Please ensure you include a CV and a cover letter with your application. As part of your cover letter, Roche is keen to understand your motivation in applying for this position.

    You should, therefore, provide responses to the following questions :

  • What is your key motivation for applying for this placement?
  • What personal qualities, skills and experience will you bring in relation to what the role will require?
  • Your cover letter should not exceed one page.

    Video Interview

    Once a HR review has been completed you may be invited to complete a video Interview to support your application.

    Stage 2 : Assessment Centre

    Assessment Centre

    If successful at the Video, CV and Cover Letter screen, you will be invited to the final stage of the application process.

    This will include a face to face interview, and relevant activities critical for the role, giving you a taste of Roche and the placement.

    The Assessment centre day will take place early February at our site in Welwyn Garden City

  • Who we are 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 an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, mental / physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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