Categories

The competition categories are reviewed annually by the Executive Steering Group to ensure we are reflecting the span of skills and competencies that make you so great at what you do.

It is important that you look at the role description and not just the category titles because titles vary from company to company. We want to ensure you get the maximum benefit from participation, by matching you with fellow participants with similar levels of responsibility.

Clinical Trial Administrator (CTA)

This category is designed to assess the required skills and competencies to be an organised and competent Clinical Trial Administrator (CTA).

Clinical Trial Administrator (CTA) – Entry guidelines and judging criteria

Aspiring and Junior Clinical Research Associate

This category is designed to challenge the ACRA’s understanding of the core aspects of the CRA responsibilities and tasks gained from ACRA training until a maximum of 6 months in a junior CRA role.

Aspiring and Junior Clinical Research Associate – Entry guidelines and judging criteria

Clinical Research Associate (CRA)

This category is designed to challenge the CRA’s understanding of the core aspects of patient safety and data integrity through rigorous site monitoring, and management.

Clinical Research Associate (CRA) – Entry guidelines and judging criteria

Project Manager (CRO)

This category is designed to challenge experienced Clinical Project Managers on their understanding of the role of the Project Manager in Clinical Research, from study award through study start to study delivery.

Project Manager (CRO) – Entry guidelines and judging criteria

Project Manager (Pharma/Biotech or Medical Device)

This category is designed to challenge experienced Clinical Project Managers on their understanding of the role of the Project Manager in Clinical Research, from study design and development of the study project plan to execution of the plan.

Project Manager (Pharma/Biotech or Medical Device) – Entry guidelines and judging criteria

Team Leader

This category is designed to assess the Team Leader’s ability to guide teams to successful outcomes.

Team Leader – Entry guidelines and judging criteria

Clinical Research Team

This category is designed to challenge the team’s understanding of the core aspects of clinical research and Good Clinical Practice. Suitable for teams of up to 4 people.

Clinical Research Team – Entry guidelines and judging criteria

Start Up

This category is designed to challenge individuals working within the Study Start Up (SSU) arena.

Start Up – Entry guidelines and judging criteria

Start Up Team

This category is designed to challenge a Team working within the Study Start Up (SSU) arena.

Start Up Team – Entry guidelines and judging criteria

Decentralised Solutions Individual of the Year

This category is designed to challenge Digital and Clinical individuals on their understanding of the importance decentralised solutions play in Clinical Research, from study design and development of relevant and appropriate solutions to execution.

Decentralised Solutions Individual of the Year – Entry guidelines and judging criteria

Decentralised Solutions Individual of the Year

Entry Guidelines and Judging Criteria

This category is designed to challenge Digital and Clinical individuals on their understanding of the importance decentralised solutions play in Clinical Research, from study design and development of relevant and appropriate solutions to execution.

SUITABILITY:

Suitable for all individuals working within digital and decentralised solutions within Pharma or Biotech, CRO and Service / Technical companies.  Roles that individuals may have could include Digital Project managers, Technical project managers, Digital solutions leads, Clinical project lead, Clinical project manager

FORMAT:

  • Finalists will be invited to take part in a category-specific case-study challenge developed by an independent expert panel.
  • Finalists will be presented with the challenge on the finals day – and given a set period of time for preparation (usually 1 hour) – before delivering their presentation to a judging panel of senior industry clinical researchers.
  • Finalists will be questioned on key decentralised solution competencies to assess their understanding of them in relation to their role.

JUDGING CRITERIA:

Specific scoring criteria are utilised alongside each year’s unique case-study / challenge.  Finalists will be expected to demonstrate the following core project management skills:

  • Assimilate clinical information in the challenge
  • Development of a detailed and relevant decentralised solution plan
  • Knowledge and application of ICH-GCP and relevant regulatory guidances
  • Knowledge of requirements for selection of the relevant solutions
  • Knowledge and application of the relevant solutions
  • Ability to identify and deploy/oversee novel clinical trial technologies
  • Approaches to tracking and monitoring/oversight of implementation of the solutions with particular focus on the benefits for patient identification, recruitment, retention and diversity and the reduction of burden for the patient and site whilst ensuring high quality data is delivered.
  • Ability to effectively present and communicate study solution within specified time limit for presentation
  • Ability to competently address questions and provide clear answers to the judges’ satisfaction

Start Up Teams

Entry Guidelines and Judging Criteria

This category is designed to challenge a Team working within the Study Start Up (SSU) arena. As a Team you will be tested on your SSU knowledge as well as your creativity to think outside the box. Your understanding of planning, strategy, timelines and delivering first time quality will be tested on the day. In addition to considering the team you work with on your project or within your country, team members can also include multidisciplinary colleagues working in various roles, different projects or different countries.

SUITABILITY:

Suitable for any Team working within the start-up phase of a clinical trial. The minimum team should be 3 people and max 5.

FORMAT:

  • Finalists will be invited to take part in a category-specific case-study challenge developed by an independent expert panel.
  • Finalists will be presented with various challenges throughout the day and will be observed by a judging panel of senior industry leaders.

JUDGING CRITERIA:

Specific scoring criteria will be developed alongside the challenges. Team finalists will be expected to demonstrate the following skills:

  • Awareness of scope and challenges
  • Ability to interpret the challenge and develop a strategy
  • Understanding of the priorities
  • Risk assessment and mitigation
  • Managing operational delivery
  • Tracking performance
  • Metrics and KPIs
  • Quality: TMF and Query Management
  • Teamwork
  • Communication
  • Managing client expectations

Start Up Individuals

Entry Guidelines and Judging Criteria

This category is designed to challenge individuals working within the Study Start Up (SSU) arena. You will be tested on your SSU knowledge as well as your creativity to think outside the box. Your understanding of planning, strategy, timelines and delivering first time quality will be tested on the day.

SUITABILITY:

Suitable for any individual working within the start-up phase of a clinical trial.

FORMAT:

* Finalists will be invited to take part in a category-specific case-study challenge developed by an independent expert panel.

* Finalists will be presented with the challenge on arrival at the finals day and given a set period of time for preparation (usually 1 hour) before delivering their response to a judging panel of senior industry leaders.

JUDGING CRITERIA:

Specific scoring criteria will be developed alongside each year’s unique challenge. Individual finalists will be expected to demonstrate the following skills:

  • Awareness of scope and challenges
  • Ability to interpret the challenge and develop a strategy
  • Understanding of the priorities
  • Risk assessment and mitigation
  • Managing operational delivery
  • Tracking performance
  • Metrics and KPIs
  • Quality: TMF and Query Management
  • Teamwork
  • Communication
  • Managing client expectations

Clinical Site Team

Entry Guidelines and Judging Criteria

OVERVIEW:

This category is designed to challenge clinical site teams, delivering clinical trials across the UK. The team should be able to demonstrate insight into the clinical research environment and the skill sets needed to work as a team to deliver excellence in the setting up and conduct of trials.

Sponsored by the National Institute of Health and Care Research (NIHR) and the Association of the British Pharmaceutical Industry (ABPI), this category is an opportunity to showcase best practice in trial delivery, that helps the UK enhance its global attractiveness for clinical research.

Entry Guidelines and Judging Criteria

WHO CAN APPLY?

Teams may comprise up to three members drawn from the personnel who contribute to the conduct of clinical trials including, but not limited to, investigators, research nurses, research office staff and clinical trials support staff. Entries are invited from highly motivated teams committed to excellence who are working in any phase of clinical development in hospital, university, general practice, or industry-based settings. This category is not open to non-UK entrants.

COMPETITION STAGES:

Similarly to the other categories in this competition, this category comprises of three stages – as described below and in “How it Works”.

Clinical Trial Site – First Stage Clinical Challenge

This is an online multiple-choice questionnaire prepared by the Institute of Clinical Research (ICR) consisting of 20 questions based on ICH/GCP questions. The pass mark to move forward to Stage 2 is 80%. One re-take is allowed. This can be completed as a team or one person can be nominated to complete it on behalf of their team.

Successful teams from stage one are then invited to complete stage two.

Clinical Trial Site – Second Stage Clinical Challenge

At stage two, entrants are required to complete a category specific 'Clinical Challenge' devised by the competition's Executive Steering Group.

Clinical trial site teams will be asked to submit a Powerpoint presentation focussed on a broad question that will permit the team to show their insights into clinical trials. Teams will be informed of this question at the start of the challenge.

Submissions are anonymised and then shared with the judging panel, who will assess the submissions based on the overall judging criteria comprising of a set of ideal responses, plus additional criteria specific to this year’s unique challenge.

The top performers are then invited to compete in the finals (Stage 3).

Clinical Trial Site – Third Stage: The Finals – Virtual

24th March 2023

Teams who make it to stage 3 will be given a challenge on the day to complete as a team. No preparation will be required prior to the finals.

Judges are drawn from the competition steering group – and entrants are only judged by people from outside their own organisation.

Judging Criteria

Finalists will be expected to demonstrate the following core competencies:

  • Understanding of the clinical research environment and the key drivers
  • Insight into making optimal use of resources
  • Importance of teamwork and communication
  • Planning and organisational skills
  • Results focus and ensuring delivery

Clinical Research Team

Entry Guidelines and Judging Criteria

This category is designed to challenge team’s understanding of the core aspects of clinical research and Good Clinical Practice.  Your understanding of study management, clinical research and quality requirements will be tested on the finals day. 

SUITABILITY:

Suitable for teams of up to 4 people. The team can consist of people with multifunctional backgrounds with the ability to work through clinical research challenges. A team can be from a single entity (Pharma/CRO/Biotech/Consumer Health/Academic Research Unit) or be a combination of Pharma/ CRO/Vendors and study/trial site team members.

FORMAT:

Finalists will be invited to take part in a team final day of multiple challenges, normally in person.

JUDGING CRITERIA:

Specific scoring criteria will be developed alongside each year’s challenges.  As well as understanding the challenges, teams will be expected to demonstrate team working and the ability as a team to achieve common goals

In-House CRA of the Year

OVERVIEW:

This category is designed to challenge the In-House CRA’s understanding of the core aspects of the role within the clinical monitoring function.  Your understanding will be tested on the day.

SUITABILITY:

Suitable for those currently working in the role of In-House CRA/ Remote Monitor. It is expected that those entering the competition will have been in the role for a minimum of 6 months at the point of entering the competition.

FORMAT:

* Finalists will be invited to take part in category-specific case-study challenges developed by an independent expert panel.

* Finalists will be presented with the challenge on arrival at the finals day – and given a set period of time for preparation (usually 1 hour) – before delivering their response to a judging panel of senior clinical research and industry leaders.

JUDGING CRITERIA:

Specific scoring criteria will be developed alongside each year’s unique case-study / challenge.  As well as understanding the case study and challenges, In-House CRA finalists will be expected to demonstrate the following core skills:

  • Ability to understand the clinical and business    implications of the scenario provided
  • Ability to define the core strategic challenge
  • Demonstrate in-depth knowledge (including ICH-GCP ) and application of the role of the IHCRA (which can vary between companies)
  • Develop a situational analysis
  • Identify solutions and contingencies
  • Demonstrate understanding of the advantages of collaboration and benefits of teamworking

Team Leader

Entry Guidelines and Judging Criteria

OVERVIEW:

This category is designed to assess the Team Leader’s ability to guide teams to successful outcomes.

SUITABILITY:

Suitable for experienced Team Leaders who can demonstrate a successful track record in leading teams to positive outcomes. During the assessment process we will be looking for real life examples of issues faced, action plans developed, and results obtained.

FORMAT:

* On successful completion of the MCQ, candidates will be invited to submit their response to a Team Leader challenge developed by an independent panel of judges.

* Our judges will select the top candidates to participate in the finals day challenge which consists of two parts. Part 1 is the individual challenge which candidates will be asked to prepare in advance. Part 2 is a group challenge that will be shared with the finalists on finals day, be prepared to be interactive, creative and enjoy presenting as a team of finalists to the judging panel of experts and industry leaders.

JUDGING CRITERIA:

Specific scoring criteria will be developed in association with each unique challenge.  The Team Leader finalists will need to indicate a comprehensive understanding of the challenge presented and be able to demonstrate the following:

  • Expertise within the area of Clinical Research in which the Team Leader works. Examples include: Clinical Operations, Project Management, Quality, Data Management, Medical, Safety, Finance, IT, Business Development
  • Strong, effective leadership skills and an ability to guide teams to successful outcomes
  • Flexible, effective interpersonal skills
  • Awareness and utilisation of team member skill sets in association with team member development
  • Risk assessment, issue prioritisation and awareness of implications
  • Ability to resolve conflict

Project Manager (Pharma/Biotech or Medical Device)

Entry Guidelines and Judging Criteria

This category is designed to challenge experienced Clinical Project Managers on their understanding of the role of the Project Manager in Clinical Research, from study design and development of the study project plan to execution of the plan.

SUITABILITY:

Suitable for Clinical Project Managers with at least 3 years’ experience in a Pharma or Biotech or Medical Device setting.  Roles that Project Managers may be engaged in include Local/Global Study Manager, Clinical Study Leader, Clinical Project Manager, Clinical Trial Manager or Clinical Operations Leader.

FORMAT:

  • Finalists will be invited to take part in a category-specific case-study challenge developed by an independent expert panel.
  • Finalists will be presented with the challenge on the finals day – and given a set period of time for preparation (usually 1 hour) – before delivering their presentation to a judging panel of senior industry clinical researchers.
  • Finalists will be questioned on key Project Manager competencies to assess their understanding of them in relation to their role.

JUDGING CRITERIA:

Specific scoring criteria are utilised alongside each year’s unique case-study / challenge.  Project Manager finalists will be expected to demonstrate the following core project management skills:

  • Assimilate clinical information in the challenge
  • Development of a detailed project management plan
  • Knowledge and application of ICH-GCP and relevant regulatory guidances
  • Knowledge of requirements for selection and oversight of 3rd party providers (CROs, clinical labs, EDC, PRO etc)
  • Knowledge and application of clinical monitoring approaches
  • Development of/or oversight of clinical project management solutions and implementation plans
  • Ability to identify and deploy/oversee novel clinical trial technologies
  • Approaches to tracking and monitoring/oversight of implementation of the project plan

Project Manager (CRO)

Entry Guidelines and Judging Criteria

This category is designed to challenge experienced Clinical Project Managers on their understanding of the role of the Project Manager in Clinical Research, from study award through study start to study delivery.

SUITABILITY:

Suitable for Clinical Project Managers with at least 3 years’ experience working in a CRO.  Roles that Project Managers may be engaged in include Local/Global Study Manager, Clinical Study Leader, Clinical Project Manager, Clinical Trial Manager or Clinical Operations Leader.

FORMAT:

  • Finalists will be invited to take part in a category-specific case-study challenge developed by an independent expert panel.
  • Finalists will be presented with the challenge on the finals day – and given a set period of time for preparation (usually 1 hour) – before delivering their presentation to a judging panel of senior industry clinical researchers.
  • Finalists will be questioned on key Project Manager competencies to assess their understanding of them in relation to their role.

JUDGING CRITERIA:

Specific scoring criteria are utilised alongside each year’s unique case-study / challenge.  Project Manager finalists will be expected to demonstrate the following core project management skills:

  • Assimilate clinical information in the challenge
  • Development of a detailed project management plan
  • Knowledge and application of ICH-GCP and relevant regulatory guidances
  • Knowledge and application of clinical monitoring approaches
  • Development of clinical project management solutions and implementation plans
  • Ability to deploy novel clinical trial technologies
  • Approaches to tracking and monitoring implementation of the project plan

Clinical Research Associate (CRA)

Entry Guidelines and Judging Criteria

OVERVIEW:

This category is designed to challenge the CRA’s understanding of the core aspects of patient safety and data integrity through rigorous site monitoring, and management.  Your understanding of the CRA role, from developing of a monitoring plan, execution of the study conducts to the close out of the study at a site level will be tested.

SUITABILITY:

Suitable for experienced CRAs with 1+ years site monitoring and management experience.

FORMAT:

* Finalists will be invited to take part in category-specific case-study challenges developed by an independent expert panel.

* Finalists will be presented with the ‘live’ challenge on arrival at the finals day, where given a set period of time for preparation (max 1 hour) – before delivering their response to a judging panel of senior marketing and industry leaders.

JUDGING CRITERIA:

Specific scoring criteria will be developed alongside each year’s unique case-study / challenge.  As well as understanding the case study and challenges, CRA finalists will be expected to demonstrate the following core CRA skills:

  • Ability to define the core strategic challenge
  • Ability to assimilate the study protocol information for quality site management of patient safety and data integrity.
  • Show ability to analyse the data available
  • Knowledge and application of site monitoring
  • Demonstrate ability to identify issues, action items with the ability to work to their resolution considering other study team members / site staff involved. Develop solutions and implement plans
  • Show high quality ability to perform Risk Based Monitoring and know the key drivers

Aspiring CRA and Junior CRA

Entry Guidelines and Judging Criteria

OVERVIEW:

This category is designed to challenge the ACRA’s and Junior CRA’s understanding of the core aspects of CRA responsibilities and tasks. On the day your understanding of core aspects will be tested.

SUITABILITY:

Entries are invited from those with ambition to become CRAs and those already in the CRA role for 6 months at time of entering this competition.

This category is open to those working in a clinical research environment.

Candidates will include Clinical Trial Assistants and other clinical research clerical /administrative staff including those working in the NHS, staff working in regulatory affairs, R&D, pharmacovigilance and medical information. Entries from students aspiring to a career as a CRA are also welcome. 

ACRAs who are in training or completed training and those who have been in the CRA role for a maximum of 6 months will be eligible

FORMAT:

  • Competency based assessment relevant for the role
  • Essay (1000 words)

* Finalists will be invited to take part in category-specific case-study challenge developed by an independent expert panel.

* Finalists will be presented with the challenge on the finals day – and given a set period of time for preparation (usually 1 hour) – before delivering their response to a judging panel of senior industry leaders.

JUDGING CRITERIA:

Specific scoring criteria will be developed alongside each case-study / challenge.  As well as understanding the case study and challenge, ACRA finalists will be expected to demonstrate the following:

  • Ability to assimilate information
  • Development of a situational analysis
  • Ability to define the ACRA challenge
  • Knowledge and application of ACRA skill set
  • Management of situational challenges
  • Ability to identify and address routine CRA tasks and challenges
  • Understanding and application of ICH-GCP

Clinical Trial Administrator (CTA)

Entry Guidelines and Judging Criteria

OVERVIEW:

This category is designed to assess the required skills and competencies to be an organised and competent Clinical Trial Administrator (CTA).

SUITABILITY:

Suitable for new CTAs with approximately 6 months experience, alongside experienced CTAs too.  Assessment will be focussed on their range and depth of knowledge irrespective of years in the role.

FORMAT:

  • Finalists will be invited to take part in category-specific case-study challenges developed by an independent expert panel.
  • Finalists will presented with the challenge on arrival at the finals day – and given a set period of time for preparation (usually between 45 mins to an 1 hour) – before delivering their response to a judging panel of industry leaders.

JUDGING CRITERIA:

Specific scoring criteria will be developed alongside each year’s unique case-study / challenge.  As well as understanding the case study and challenges, CTA finalists will be expected to demonstrate through their own experiences the following core skills:

  • Demonstrate a key strategy to answering the challenge under pressurised time period
  • Ability to assess priorities and develop an action plan accordingly
  • Be able to explain the reason for their priorities in the context of clinical trial execution
  • Understand the fundamental skills of a successful CTA
  • Demonstrate the key competencies that a CTA should have when supporting the team
  • Demonstrate their initiative when faced with conflicting task execution
  • Approaches to tracking and monitoring implementation