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• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.    Works    together    with    Regulatory    Affairs    to    ensure    timely    delivery    of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely  preparation  of  country  financial  Study  Management  Agreement  (fSMA)  and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant  SOPs and local regulations.
• Ensures 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 setting sites ready to enrol, and in line with  SOPs.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
• Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads National Investigator meetings, in line with local codes, as required.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and Procedural Documents.
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline bmanner to maintain the eTMF “Inspection Ready”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Ensures compliance with company Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line  Management.

Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).

• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
• Good knowledge of international guidelines ICH- GCP as well as relevant local regulations.
• Excellent project management skill
• Excellent team building and interpersonal skills
• Excellent organisational skills
• Excellent verbal  and  written  communication skills
• Excellent ability to prioritize and handle multiple tasks
• Excellent attention to details
• Excellent  knowledge  of  spoken  and  written English
• Good negotiation skills

Good ability to learn and to adapt to work with IT systems.


Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing 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 in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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