This is an exciting opportunity to join ICON
Clinical Trial Manager - Respiratory
Homebased - any US location
Job Profile Summary
- To act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies.
- To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study
- For the delivery of all aspects of monitoring and site management
- Ensuring consistency with ICH/GCP and applicable ICON Standard Operating Procedures (SOPs), applicable regulations, the Monitoring Plan and ensuring the clinical portion of the study is inspection ready at all times.
- Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.
- As a Professional, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs.
- Participate in opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices.
- Travel (approximately 25%) domestic and/or international.
- Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.
- Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management, timely investigator payments.
- Responsible for driving enrolment as per contracted timelines.
- Regular oversight of key clinical metrics including but not limited to: Days on Site (DOS), Monitoring Visit Report (MVR) and Follow up Letters (FUL) timelines, Action Items (AI) and other quality metrics, to ensure they are met and followed-up as necessary.
- Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and interacting with the Central Visit Report Approvers, as appropriate.
- Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner.
- Contribute to the development and maintenance of all clinical elements of cross functional project plans.
- Able to work on multinational studies and may take the role of a Global CTM if appropriate.
- Responsible for coordinating and managing the clinical project team to ensure:
- high performance and productivity (e.g. DOS for CRAs)
- optimal utilization
- minimal turnover
all necessary project training is provided, documented and filed appropriately.
- Responsible for documenting clinical risks and developing mitigation strategies and associated action plans, including issue escalation and resolution.
- Responsible for the development and maintenance of operational plans for clinical deliverables e.g. CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc.
- Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary. This includes documented QC checks of in house investigator site files.
- Ensure all close-out activities are completed as necessary e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved.
- Lead and/or actively participate in the conduct of clinical team meetings.
- Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables.
- Implement QC activities, ensure compliance with quality measures and monitor required quality metrics.
- Maintain confidentiality of information, as appropriate.
- Participate in business development activities such as bid defense meetings
- May be required to undertake individual, finite PM tasks under supervision and with support of the Line Manager.
- Participate in Company/Departmental initiatives, as requested.
- Undertake other reasonably related duties as assigned.
- Previous working experience within the clinical trial management field specifically in respiratory and/or other general medicine indications.
- University/Bachelor's Degree in medicine, science or equivalent degree/experience.
- A satisfactory progression of monitoring experience with previous experience in leadership and/or management activities
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
- Some knowledge of project management processes and tools.
- Fluent in written and spoken English
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.