Local Study Associate Director Job at iconplc

Job Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Responsibility

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality
Leads and optimizes 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
Organizes 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.

Requirements

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

What we offer

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 for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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Local Study Associate Director

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