[Register Your Interest] Clinical Operations Industrial Placement - 2022 Intake

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Clinical Operations Industrial Placement

GSK are a science-led global healthcare company that researches and develops innovative Pharmaceuticals, Vaccines and Consumer Healthcare products. Our challenging and inspiring mission is to enable people to do more, feel better and live longer by developing innovative products and improving access to healthcare for patients around the world.

Whatever the role, you will experience working in a fast-paced research environment with access to cutting edge technology, whilst interacting with industry-leading scientists across multiple disciplines and sharing different experiences. During the internship, the IP student will be supported, given training (laboratory and office practices) daily where applicable until confident to work independently and within GSK health and safety requirements, enrolled in several GSK internal courses as part of company policy, enrol in personal development courses and networking opportunities throughout the year and attend seminars led by GSK scientists.

Before a new medicine can be marketed for use in humans, it is necessary to confirm that it is safe and effective. We do this by carrying out clinical trials. The Clinical Operations department has accountability for the on time on budget delivery of clinical trials to the highest scientific, quality and ethical standards. We are looking for students who can work well as part of a team and, as needed, independently with appropriate time management, flexibility and attention to detail. You must be reliable, enthusiastic, have a proactive attitude and be self-motivated with good written and verbal communication skills. You will be computer literate in MS Word, MS PowerPoint and Excel. It is important you can build strong relationships and have the ability to influence others.

Please read below about the positions we are recruiting for, when you apply you will be able to select 3 preferences. We will accommodate your preference where possible.

Please note: these are office-based roles and not laboratory-based placements.

Role 1: Associate Clinical Development Scientist (Study Management)

Within this role your day-to-day responsibilities will be involved in the testing of new (un-marketed) medicines in humans. Your responsibilities may include but are not limited to:

• Participating in scientific discussions relating to the design of clinical studies
• Preparation of high-quality scientific materials relating to clinical trials (including, for example: contributing to clinical study protocols, procedures manuals, information and consent forms)
• Operational delivery of clinical studies (including, for example: feasibility assessments, overseeing subcontractors/vendors performance, recruitment tracking)
• Attendance at and contribution to clinical study team meetings.
• Review of data and writing of associated reports.
• Assist with planning and tracking of study timelines and budgets.
• Co-ordinate key study activities such as study documentation filing, study supplies and investigator meetings.

You may also be asked to assist with other departmental activities that are not study related.

Role 2: Associate Clinical Development Scientist (Delivery Optimisation and Informatics)

Within this role your day-to-day responsibilities will be involved in improving GSK clinical trials processes and investigation of new technologies, process, data sources and integrations. Your responsibilities may include but are not limited to:

• Working on protocol design lab to assist in the set-up and management of the meetings
• Working on possible new data sources to supplement those we are already using e.g. TAscan.
• Working on new decentralised study technologies and processes and help with their monitoring and embedding in GSK
• Working on the ‘horizon’ planning and link to the study design and delivery optimisation process.
• Work with R+D tech on the further development of a workflow orchestration tool to manage all aspects of study design, set-up, data integration and visualisations.

Role 3: Assistant Study start-up lead

You will work as an Assistant Study Start-Up Lead (ASSUL) supporting Global GSK Sponsored R&D Trials, across Phases I – IV, in various therapy areas ensuring the timely set-up and initiation of clinical trials.

You will gain experience in the following areas:

• Coordination and Planning: Supporting study teams in coordinating core operational set-up activities under the oversight of the Study Set-Up Lead (SSUL), working in conjunction with our strategic planning team
• Monitoring delivery of set-up activities against plan in both central team (UK/US based) and Local Operating Companies (our country-based staff)
• Operational Delivery: Supporting the SSUL in delivering core set-up tasks such as assessing whether a clinical trial is feasible before it is started
• Matrix Working & Communication: Contributing and liaising with multiple functional groups both UK based and across our global footprint countries
• Process Development: The potential to be involved in groups improving our set-up processes to ensure we work within a robust framework in an industry that is continuously developing
• Team working: Potentially will also be part of some of the committees at GSK which organise events, charity days. This will help with building organisational skills, teamwork and exposure to more people working in different departments of the company.
• Pharmaceutical Development: To gain a broad understanding of the pharmaceutical industry, the student will be able to go with other students on one-day trips to other local GSK sites and business units to understand the functions performed there

Role 4: Clinical Development Associate

This role is based in GSK’s Phase 1 Clinical unit situated within Addenbrookes Hospital. The role holder will provide project management, operational and technical support to the Clinical Development Managers (CDM) and study teams. This will include:

• Support study set up and project management activities
• Support and assist coordination of the required ethics application of designated studies.
• Focus on study set- up and operational project management and close out activities.

Working with the CDM team the student will learn:

• To ensure compliance with regulatory and ethical standards.
• Maintain accurate and complete study records consistent with company policy and legal and regulatory requirements.
• Site file maintenance to ensure accurate maintenance of study records for monitoring and inspection-readiness of the site investigator file.
• Support study scheduling, management of bed occupancy spreadsheet and planning clinical timelines
• Develop and maintain study budgets.
• Identify and implement process improvements.
• Team leadership, management and communication, including meeting management with the unit and GSK study teams.
• Support the day to day management and running of clinical trials, supporting the clinical teams.

Role 5: Associate Clinical Data Manager

This placement will provide an opportunity for students to support certain clinical trials as an Associate Clinical Data Manager. These trials are a key part of the drug discovery and development process for new medicines in therapy areas.

Students will gain experience in the following areas:

• Clinical trials: Working with the data collected on a clinical trial (demography data, disease characteristics data, lab data, radiology data, safety and efficacy data) and ensuring the data is collected correctly by interrogating the data using computerised checks or manually reviewing the data using various systems. Involved in the set up or management of Phase 1/2/3 clinical trials.
• Clinical trial Systems: Collaborate with a variety of people who work in clinical trials internationally e.g. scientists, operations, safety, site staff, and equipment or lab providers. They will use a variety of different databases and systems as they conduct their work.
• Therapy area knowledge: Work in one of three therapy areas - Immune-inflammatory, Infectious Disease, Oncology. Understand the clinical protocols for each trial that they support.
• Data Management: Learn the role of data management in clinical trials and the various activities that need to be performed to ensure that data is acquired and validated effectively so that it meets the required quality and privacy standards for a successful trial.
• Pharmaceutical Development: Gain a broad understanding of the pharmaceutical industry. Join other students on one day trips to other local GSK sites and business units to understand the functions performed there.

About GSK

One of the world’s leading healthcare companies, GSK discovers, develops, manufactures and distributes life-saving vaccines, prescription medicines and consumer health products such as Maxinutrition, Sensodyne, Aquafresh and Panadol.

The size and scope of our organisation allows our people to answer some of the biggest questions facing everyone on the planet – questions about future healthcare needs and questions about building a responsive, innovative, global business to meet them – as well as questions about their own personal and professional growth.