ICON
Overview
Local Study Associate Director
ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment that drives innovation and excellence. Join us in shaping the future of clinical development.
What you will be doing
Have the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Lead and optimize the performance of the Local Study Team(s) at country level, ensuring compliance with Procedural Documents, ICH-GCP, and local regulations.
Ensure, as required, that clinical and operational feasibility assessments of potential studies are performed to the highest quality.
Coordinate the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessments, and conducting Site Qualification Visits to evaluate suitability and quality risks.
Ensure timely submission of applications/documents to EC/IRB at startup and throughout the study. Work with Regulatory Affairs to ensure timely delivery of applications/documents for submissions to Regulatory Authorities for the duration of the study, and in line with local regulations.
Ensure timely preparation of the country financial Study Management Agreement (fSMA) and maintain accurate study budget in the AZ clinical studies financial system through regular checks of the system and financial reports (as agreed with the Director, SMM/Director, Country Head).
Ensure timely preparation of local Master CSA (including site budget) and amendments as needed.
Ensure timely preparation of country-level Master Informed Consent Form (MICF) and subsequent site-level ICFs, as required, including relevant translations, and in line with SOPs and local regulations.
Ensure all country and site-level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to site readiness for enrollment, and in line with SOPs.
Plan and coordinate applicable local drug activities (from local purchase or reimbursement to drug destruction).
Set up and maintain the study in CTMS at country study level as well as local websites as required by local laws and regulations.
Oversee, manage and coordinate monitoring activities from site activation through to study closure at country and site level in accordance with Monitoring Plans.
Review monitoring visit reports and pro-actively advise monitors on study-related matters.
Perform any required co-monitoring, accompanied Site Visits/training visits with study CRAs.
Proactively identify risks and facilitate resolution of complex study problems and issues.
Organize regular Local Study Team meetings on an agenda-driven basis.
Build good working relationships with all Local Study Team members, sites’ staff, and global stakeholders.
Report study progress/updates to the Global Study Associate Director/Global Study Team including the SMM Lead.
Contribute to patient recruitment strategy including regular communication with participating Investigators as necessary.
Develop, maintain and review risk management plans at country study level; proactively manage sites, stakeholders, local and global vendors and customers to ensure risks are identified and mitigated.
Communicate and coordinate regularly with National Coordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
Plan and lead National Investigator meetings, in line with local codes, as required.
Assist in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
Ensure systems required to facilitate business-critical activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set up, updated and access is organized at country level.
Ensure accurate payments related to the study are performed according to local regulations and agreements.
Participate in training and coaching new Local Study Team members, ensuring compliance with ICH-GCP and Procedural Documents.
Ensure completeness of the eTMF and that essential documents are uploaded in a timely manner to maintain the eTMF as "Inspection Ready".
Ensure that all study documents are ready for final archiving and completion of the local part of the eTMF.
Plan and lead activities associated with audits and regulatory inspections in liaison with CQAD and QA.
Provide input to process development and improvement.
Provide regular information to Line Managers at country level on studies and planned study milestones/key issues.
Update Line Managers about the performance of the CRAs/CSAs.
Ensure study activities at country level comply with local policies and codes of ethics.
Provide feedback on research-related information including sites/investigators/competing studies that might be useful for the local market.
Ensure compliance with the company Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Collaborate with the local Medical Affairs team.
Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
Your profile
Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
Five years of US-focused clinical trial management experience, including budget oversight.
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
Excellent project management skills.
Excellent team-building and interpersonal skills.
Excellent organizational skills.
Excellent verbal and written communication skills.
Excellent ability to prioritize and handle multiple tasks.
Excellent attention to detail.
Excellent knowledge of spoken and written English.
Good ability to learn and adapt to work with IT systems.
Location: US remote
What ICON can offer you Our success depends on the quality of our people. We are committed to building a diverse culture that rewards high performance and nurtures talent.
In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Visit the careers site to read more about the benefits ICON offers.
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please let us know.
Interested in the role but unsure if you meet all of the requirements? We encourage you to apply regardless—there’s every chance you’re exactly what we’re looking for here at ICON.
Are you a current ICON employee? Please apply here.
#J-18808-Ljbffr
ICON plc is a world-leading healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment that drives innovation and excellence. Join us in shaping the future of clinical development.
What you will be doing
Have the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Lead and optimize the performance of the Local Study Team(s) at country level, ensuring compliance with Procedural Documents, ICH-GCP, and local regulations.
Ensure, as required, that clinical and operational feasibility assessments of potential studies are performed to the highest quality.
Coordinate the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessments, and conducting Site Qualification Visits to evaluate suitability and quality risks.
Ensure timely submission of applications/documents to EC/IRB at startup and throughout the study. Work with Regulatory Affairs to ensure timely delivery of applications/documents for submissions to Regulatory Authorities for the duration of the study, and in line with local regulations.
Ensure timely preparation of the country financial Study Management Agreement (fSMA) and maintain accurate study budget in the AZ clinical studies financial system through regular checks of the system and financial reports (as agreed with the Director, SMM/Director, Country Head).
Ensure timely preparation of local Master CSA (including site budget) and amendments as needed.
Ensure timely preparation of country-level Master Informed Consent Form (MICF) and subsequent site-level ICFs, as required, including relevant translations, and in line with SOPs and local regulations.
Ensure all country and site-level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to site readiness for enrollment, and in line with SOPs.
Plan and coordinate applicable local drug activities (from local purchase or reimbursement to drug destruction).
Set up and maintain the study in CTMS at country study level as well as local websites as required by local laws and regulations.
Oversee, manage and coordinate monitoring activities from site activation through to study closure at country and site level in accordance with Monitoring Plans.
Review monitoring visit reports and pro-actively advise monitors on study-related matters.
Perform any required co-monitoring, accompanied Site Visits/training visits with study CRAs.
Proactively identify risks and facilitate resolution of complex study problems and issues.
Organize regular Local Study Team meetings on an agenda-driven basis.
Build good working relationships with all Local Study Team members, sites’ staff, and global stakeholders.
Report study progress/updates to the Global Study Associate Director/Global Study Team including the SMM Lead.
Contribute to patient recruitment strategy including regular communication with participating Investigators as necessary.
Develop, maintain and review risk management plans at country study level; proactively manage sites, stakeholders, local and global vendors and customers to ensure risks are identified and mitigated.
Communicate and coordinate regularly with National Coordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
Plan and lead National Investigator meetings, in line with local codes, as required.
Assist in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
Ensure systems required to facilitate business-critical activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set up, updated and access is organized at country level.
Ensure accurate payments related to the study are performed according to local regulations and agreements.
Participate in training and coaching new Local Study Team members, ensuring compliance with ICH-GCP and Procedural Documents.
Ensure completeness of the eTMF and that essential documents are uploaded in a timely manner to maintain the eTMF as "Inspection Ready".
Ensure that all study documents are ready for final archiving and completion of the local part of the eTMF.
Plan and lead activities associated with audits and regulatory inspections in liaison with CQAD and QA.
Provide input to process development and improvement.
Provide regular information to Line Managers at country level on studies and planned study milestones/key issues.
Update Line Managers about the performance of the CRAs/CSAs.
Ensure study activities at country level comply with local policies and codes of ethics.
Provide feedback on research-related information including sites/investigators/competing studies that might be useful for the local market.
Ensure compliance with the company Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Collaborate with the local Medical Affairs team.
Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
Your profile
Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
Five years of US-focused clinical trial management experience, including budget oversight.
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
Excellent project management skills.
Excellent team-building and interpersonal skills.
Excellent organizational skills.
Excellent verbal and written communication skills.
Excellent ability to prioritize and handle multiple tasks.
Excellent attention to detail.
Excellent knowledge of spoken and written English.
Good ability to learn and adapt to work with IT systems.
Location: US remote
What ICON can offer you Our success depends on the quality of our people. We are committed to building a diverse culture that rewards high performance and nurtures talent.
In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others
Visit the careers site to read more about the benefits ICON offers.
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please let us know.
Interested in the role but unsure if you meet all of the requirements? We encourage you to apply regardless—there’s every chance you’re exactly what we’re looking for here at ICON.
Are you a current ICON employee? Please apply here.
#J-18808-Ljbffr