hVIVO Services Limited ruDzKae
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Serve as central point of contact within Clinical Site for all study related questions, correspondence and information.
OverviewhVIVO conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methods. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely - or at least make treatment of them as easy and effective as possible. Volunteers are central to the work that we do. Our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
The Clinical Study Lead is responsible for providing site project coordination of all activities associated with hVIVO's clinical studies covering all phases from screening to follow up.
The CSL will work closely with key stakeholders, serving as the local site representative at project team meetings, and collecting and reporting information on site-specific study progress back to Project Management for dissemination internally and externally to sponsors. The CSL serves as the clinical site protocol expert, providing direction and guidance to clinical staff.
All tasks are performed in accordance with current regulatory, ICH-GCP. Standards and requirements and hVIVO standard operating procedures and policies.
This role will be based accross our sites in Whitechapel & Canary Wharf.
Main Responsibilities
- Serve as central point of contact within Clinical Site for all study related questions, correspondence and information. Represents Clinical Site at all hVIVO Study team meetings (including sponsor initiative visits, kick off and lessons learned meetings);
- Assist the Site Leadership Team with the clinical and logistical evaluation of proposed hVIVO clinical trials, feeding back to the study design team with key input, feedback and ideas;
- Lead and coordinate the development and content of study specific training. Ensure appropriate approval is obtained and training is provided to and documented for applicable staff;
- Oversee completion of site specific project related documentation (i.e., delegation logs, Financial Disclosures, etc.), ensuring adequate and accurate study administration work processes are in place at site;
- Ensure that documentation is prepared within deadlines and filed appropriately within the site ISF.
- Monitor study progress to ensure compliance with and adherence to both the central and site project plan and to identify, evaluate and rectify problems;
- Provide guidance and mentoring to staff in the clinical environment, ensuring competence in performing their own and team's daily tasks;
- Involvement in preparation, planning and execution of study related clinical activities;
- Develop and/or review and complete study related documents e.g. Standard Operating Procedures (SOP), logs, source data and CRF's;
- Promote and adhere to Company SOP's, protocols and Health and Safety Regulations
Skills & Experiences
- University/college degree (life science preferred)
- Demonstrable good organisational and time management skills
- Ability to influence colleagues within a matrix structure
- Ability to use a wide range of Microsoft Office packages at the advanced level
- Good interpersonal and communication skills and ability to adjust communication to different target groups
- Good knowledge of ICH GCP & regulatory standards
- Good understanding of safeguarding confidential information required
- Skilful in creating and delivering technical clinical research skills training based on the study delivery needs
- Consultative approach, ability to advise on most suitable approach to deliver the study
- Demonstrated broad working experience in clinical research setting
- Extensive previous study coordination experience within Clinical Research
- Experience demonstrating the ability to work with minimal supervision and the ability to prioritize and organize work is required
Overview
hVIVO conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methods. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely - or at least make treatment of them as easy and effective as possible. Volunteers are central to the work that we do. Our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
The Clinical Study Lead is responsible for providing site project coordination of all activities associated with hVIVO's clinical studies covering all phases from screening to follow up.
The CSL will work closely with key stakeholders, serving as the local site representative at project team meetings, and collecting and reporting information on site-specific study progress back to Project Management for dissemination internally and externally to sponsors. The CSL serves as the clinical site protocol expert, providing direction and guidance to clinical staff.
All tasks are performed in accordance with current regulatory, ICH-GCP. Standards and requirements and hVIVO standard operating procedures and policies.
This role will be based accross our sites in Whitechapel & Canary Wharf.
Main Responsibilities
Skills & Experiences
hVIVO conducts human challenge studies offering services to both pharmaceutical and biotechnology companies using a range of different clinical trial methods. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely - or at least make treatment of them as easy and effective as possible. Volunteers are central to the work that we do. Our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
The Clinical Study Lead is responsible for providing site project coordination of all activities associated with hVIVO's clinical studies covering all phases from screening to follow up.
The CSL will work closely with key stakeholders, serving as the local site representative at project team meetings, and collecting and reporting information on site-specific study progress back to Project Management for dissemination internally and externally to sponsors. The CSL serves as the clinical site protocol expert, providing direction and guidance to clinical staff.
All tasks are performed in accordance with current regulatory, ICH-GCP. Standards and requirements and hVIVO standard operating procedures and policies.
This role will be based accross our sites in Whitechapel & Canary Wharf.
Main Responsibilities
- Serve as central point of contact within Clinical Site for all study related questions, correspondence and information. Represents Clinical Site at all hVIVO Study team meetings (including sponsor initiative visits, kick off and lessons learned meetings);
- Assist the Site Leadership Team with the clinical and logistical evaluation of proposed hVIVO clinical trials, feeding back to the study design team with key input, feedback and ideas;
- Lead and coordinate the development and content of study specific training. Ensure appropriate approval is obtained and training is provided to and documented for applicable staff;
- Oversee completion of site specific project related documentation (i.e., delegation logs, Financial Disclosures, etc.), ensuring adequate and accurate study administration work processes are in place at site;
- Ensure that documentation is prepared within deadlines and filed appropriately within the site ISF.
- Monitor study progress to ensure compliance with and adherence to both the central and site project plan and to identify, evaluate and rectify problems;
- Provide guidance and mentoring to staff in the clinical environment, ensuring competence in performing their own and team's daily tasks;
- Involvement in preparation, planning and execution of study related clinical activities;
- Develop and/or review and complete study related documents e.g. Standard Operating Procedures (SOP), logs, source data and CRF's;
- Promote and adhere to Company SOP's, protocols and Health and Safety Regulations
Skills & Experiences
- University/college degree (life science preferred)
- Demonstrable good organisational and time management skills
- Ability to influence colleagues within a matrix structure
- Ability to use a wide range of Microsoft Office packages at the advanced level
- Good interpersonal and communication skills and ability to adjust communication to different target groups
- Good knowledge of ICH GCP & regulatory standards
- Good understanding of safeguarding confidential information required
- Skilful in creating and delivering technical clinical research skills training based on the study delivery needs
- Consultative approach, ability to advise on most suitable approach to deliver the study
- Demonstrated broad working experience in clinical research setting
- Extensive previous study coordination experience within Clinical Research
- Experience demonstrating the ability to work with minimal supervision and the ability to prioritize and organize work is required
More information related to this job opportunity, from jobsincare:
Here are 20 questions you could be asked if you apply for this job:
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1. Can you tell us about your background in clinical research and how it has prepared you for the role of Clinical Study Lead?
2. What motivated you to apply for this position at hVIVO Services Limited?
3. Can you describe your experience with human challenge studies or similar clinical trial methodologies?
4. How have you applied ICH-GCP and regulatory standards in your previous roles? Can you provide specific examples?
5. Could you detail a particularly challenging project you managed in a clinical research setting? What was your role, and how did you overcome the challenges?
6. What experience do you have in developing and delivering training for clinical staff? Can you describe a successful training programme you led?
7. How do you ensure effective communication among diverse teams and stakeholders in a matrix structure?
8. Provide an example of a time when you had to influence a colleague or team to follow a specific course of action. What approach did you take?
9. What strategies do you use to monitor and report on the progress of a clinical study?
10. Describe a situation where you encountered compliance issues during a trial. How did you handle it?
11. How do you prioritise and manage documentation to ensure it is accurate and submitted on time? Can you provide an example?
12. How do you approach mentoring and guiding clinical staff to ensure their competence in daily tasks? Can you give an example?
13. What techniques do you find effective in fostering a collaborative working environment in a clinical setting?
14. What advanced Microsoft Office skills do you possess, and how have they been valuable in your previous roles?
15. Can you share a time when your organisational skills had a significant impact on the success of a project?
16. Could you walk us through your understanding of the drug development process and your experience related to it?
17. What do you consider the most critical factors for successfully conducting a clinical trial aimed at testing new treatments?
18. How do you maintain confidentiality and safeguard sensitive information in your work?
19. Describe a time when you had to adjust your communication style to effectively convey information to different target audiences.
20. What qualities do you think are essential for a Clinical Study Lead, and how do you demonstrate these qualities in your work?
1. Can you tell us about your background in clinical research and how it has prepared you for the role of Clinical Study Lead?
2. What motivated you to apply for this position at hVIVO Services Limited?
3. Can you describe your experience with human challenge studies or similar clinical trial methodologies?
4. How have you applied ICH-GCP and regulatory standards in your previous roles? Can you provide specific examples?
5. Could you detail a particularly challenging project you managed in a clinical research setting? What was your role, and how did you overcome the challenges?
6. What experience do you have in developing and delivering training for clinical staff? Can you describe a successful training programme you led?
7. How do you ensure effective communication among diverse teams and stakeholders in a matrix structure?
8. Provide an example of a time when you had to influence a colleague or team to follow a specific course of action. What approach did you take?
9. What strategies do you use to monitor and report on the progress of a clinical study?
10. Describe a situation where you encountered compliance issues during a trial. How did you handle it?
11. How do you prioritise and manage documentation to ensure it is accurate and submitted on time? Can you provide an example?
12. How do you approach mentoring and guiding clinical staff to ensure their competence in daily tasks? Can you give an example?
13. What techniques do you find effective in fostering a collaborative working environment in a clinical setting?
14. What advanced Microsoft Office skills do you possess, and how have they been valuable in your previous roles?
15. Can you share a time when your organisational skills had a significant impact on the success of a project?
16. Could you walk us through your understanding of the drug development process and your experience related to it?
17. What do you consider the most critical factors for successfully conducting a clinical trial aimed at testing new treatments?
18. How do you maintain confidentiality and safeguard sensitive information in your work?
19. Describe a time when you had to adjust your communication style to effectively convey information to different target audiences.
20. What qualities do you think are essential for a Clinical Study Lead, and how do you demonstrate these qualities in your work?
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