Clinical Operations Lead (COL) Industrial Placement Student (IPS)

As an Industrial Placement Student in Clinical Operations, you will get involved in supporting key tasks across a broad range of topics with potential to build your network outside of the department and ultimately helping accelerate drug development and successful execution of clinical trials., We are offering an outstanding opportunity for up to six Industrial Placement Students (IPS), who will be based in Welwyn Garden City, UK.

The IPS will sit within Clinical Operations and be assigned to a clinical trial as well as be part of a study and disease area community. The IPS will be included in working groups where they will have the opportunity to meet, work and collaborate with individuals in other functions outside of Operations, such as Clinical Science, Safety, Biometrics and Insights & Analytics to gain a broader understanding of roles in the Pharmaceutical industry.

The IPS will work closely with the Senior Clinical Operation Lead and Clinical Operation Leads, who are responsible for effective and efficient leadership and delivery of all operational components of a clinical trial across study start up, conduct and close-out in accordance with the appropriate quality standards including Good Clinical Practice (GCP) and applicable regulations.

Students may also have the opportunity to work with the Pharma Biosample Services group (PBS), providing support to PBS and the study teams during study close-out contributing to patients sample transfers to long term storage facilities for further exploratory research.

Key activities include:

• Clinical operations activities to ensure delivery during the lifecycle of phase I to IV studies

• Development and management of study timelines, risk and quality plans and the evaluation of study resource needs

• Providing day-to-day operational management to ensure delivery and the clinical trial runs smoothly; e.g. recruiting patients, problem solving, managing vendors/CRO’s (contract/clinical research organisations) and working with contracts.

• Working closely with our clinical research sites (hospitals) to help manage our clinical trial finances and invoicing

• Forecasting of clinical/non-clinical supplies

• Work within our safety team to process important adverse event reporting of trial subjects, and submit serious adverse reaction safety information to local ethics committees.

• You will help run reports and analysis to ensure adequate oversight of activities, such as trial master file maintenance, budget compliance and recruitment performance

• Working with PBS on Clinical Samples Long Term Storage request management activities at study closure

• Identifying areas of best practice, innovation and process improvements

• Ensuring study adherence to GCP and Standard Operations Procedures (SOPs)

• Attending/participating at Non study related activities, for example forums / departmental meetings / initiatives

Applicants should be in the penultimate or last year of study, at the "Year in Industry" junction of their studies.

If you have already graduated with a Bachelor’s degree and are currently studying a postgraduate Masters or PhD, you are not eligible for this program.

The placement is a full-time office-based role that requires your presence 5 days a week during the probationary period after which flexible working will be assessed.

To be successful in this opportunity, applicants should also have:

• Strong planning and organisational skills and the ability to manage multiple priorities at the same time

• Good communication and problem-solving skills.

• Professional, reliable, and team-orientated outlook

• Supportive and inclusive mindset, and be capable of demonstrating behaviours to work successfully in a collaborative working environment

• Awareness of your strengths and development areas

• A love of learning, shows up authentically, encourages growth and innovation and customer focused.

• Ability to come into the office for the majority of the time as well as being proficient in working in a virtual global setting when required.