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Job Details

Clinical Team Leader

Company: Chiltern
Location: Home Based anywhere in the the US
Reference: ONC CTL_CS
Closing Date: 19 May 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Home Based anywhere within the USA


Job Background

The CTL is a position of responsibility within a project with the requirement to supervise one or more CRAs as the LCRA. The CTL may also function as a Project Responsible Person (PRP) for single service studies. As a high-profile role within the project, the CTL must be able to interact confidently with the Client, maintaining a professional image when working under time constraints, and act appropriately as a representative of the Company.

CTL should be able to use their experience as a ‘knowledge resource’ for the Department and to help other CRAs develop their skills. They may be called upon to interact independently with Sponsors not directly involved in their projects, and to assist in wider Departmental tasks. The CTL role provides functional leadership to a defined group of Clinical Monitoring staff working on a designated project (the Clinical Monitoring project team) to ensure satisfactory performance and completion of the project.

1. To liaise with all Chiltern International personnel, external contractors and clients appropriately
2. To maintain awareness of current development in the therapeutic areas relevant to his/her project(s), by reading scientific and medical literature.
3. At all times to promote the image of Chiltern International, acting as an ambassador for the Company.
4. To undertake non-project related tasks as appropriate as assigned by the Line Manager
5. To ensure that all internal systems are routinely updated as appropriate (e.g. CPMS, Timesheets, Expense Claims, Productivity Reports, etc.,)
6. Contribute ideas to the development of the Department, identifying areas for improvement (e.g. SOPs, processes etc) and as appropriate contribute to Department Managers’ meetings
7. Act as a role model to their peers for departmental ‘culture’ and standards
8. Develop an understanding of the Project Management SOP and the principles of Project management
9. Ensure timely and accurate completion of expense reports in strict adherence to the Chiltern and/or sponsor travel policy(ies)
10. Provide supportive information for, and participate in, sales presentations and bid defense meetings

• A BSc or BA degree in a biomedical or related life science, or nursing qualification
• Approximately 4 years’ experience as a CRA, main function is Lead CRA for national and multinational studies.
• Demonstrated ability to conduct clinical monitoring activities effectively, efficiently and with the minimum of supervision
• Good clinical knowledge with an understanding of medical terminology
• An understanding of the basics of physiology and pharmacology
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
• Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English.
• Experience working in a team environment under time and resource pressures
• Understanding of the principles of ICH GCP and regulatory requirements
• Experience of the clinical research process and terminology
• Preferable experience using a clinical trial management system (CPMS)

• Experience as a CRA and SCRA on multicentre trials, including the Lead CRA function, and also demonstrating some of the competencies expected within a Project Management function
• Positive outlook on the role of the Department and on Departmental or Company policy
• Good understanding of the work performed by other Chiltern International functions and how they interact
• Understanding of the principles of Project Management and appreciation of the wider issues affecting the efficiency and running of the department
• Proven ability for working independently with minimal supervision
• Proven experience in all clinical aspects of a trial with a strong knowledge of SOPs and accepted practices
• Proven experience of good interpersonal and communication skills when dealing with Sponsors, supporting colleagues and making presentations
• Able to organize and oversee  multiple ongoing tasks, and understand the differing priorities
• Confident dealing with external and internal clients and providers
• Able to motivate other team members to achieve Project targets
• Proven ability to guide and supervise less experienced staff

Performance and Quality:
1. Monitor the performance of the Clinical Monitoring project team against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCPand local requirements; identify any failure to meet the standards and address the issue immediately with the individual; and if required, with their manager(s).
2. Contribute to the departmental on-site Quality Control program by setting a schedule of site assessment visits for the project for agreement with the Clinical Monitoring Management Team, and conducting agreed co-monitoring visits with members of the Clinical Monitoring project team.
3. Provide feedback (positive or negative) to Line Managers on the performance and quality of the members of the Clinical Monitoring project team for inclusion in the annual appraisal of the individuals concerned.
4. Define project-specific quality and performance standards (within Clinical Monitoring standards) and ensure these are adequately documented, communicated and understood by all members of the Clinical Monitoring project team.
5. To accompany non project CRAs on selected visits to ensure that all study related activities are being conducted according to study requirements, relevant SOPs, guidelines and regulations.
6. To support the development and delivery of department training days. To attend all relevant training and SOP training sessions.
7. Actively participate in training sessions and workshops, including presenting reports from any conferences attended
8. Ensure timely completion and documentation of all training requirements.

Please note that if your experience does not mirror that of our requirements for this role you may not receive a response.
Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.



Based on experience

Position Type

Full Time


Email Cheri Shedeck -

Apply for this job: Clinical Team Leader

Contact Information:

Address:  Illinois, USA
1425 Tri-State Parkway, Suite 110 Gurnee, USA
IL 60031
Website:  Visit Our Web Site

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