Local Trial Manager - Immunology - Home Based (US)

About the position Local Trial Manager - Immunology - Home Based (US) reputed company is a world-leading reputed company intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the future of clinical development What you will be doing: The L-reputed company role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes. The L-reputed company will serve as the country-level single reputed company of contact on the study for internal partners. While the L-reputed company may delegate tasks to other LTMs or roles on the study, the L-reputed company remains accountable for successful completion of those tasks. The L-reputed company will manage and reputed company the following throughout the study: Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable. Execution of local milestones from feasibility through study reputed company out. Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM). Inspection Readiness and AQR at the country level. reputed company collaboration with the assigned Local Trial Manager(s) (LTMs), reputed company Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and reputed company support and training, where necessary. Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to reputed company trial reputed company. Country level reputed company meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables. reputed company partnership with the study FM to reputed company updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.

Responsibilities

• Ensuring top-quality end-to-end trial delivery at a country level
• Managing the consistency of Local Trial Management duties and processes
• Serving as the country-level single reputed company of contact on the study for internal partners
• Managing and overseeing Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable
• Execution of local milestones from feasibility through study reputed company out
• Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM)
• Inspection Readiness and AQR at the country level
• reputed company collaboration with the assigned Local Trial Manager(s) (LTMs), reputed company Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and reputed company support and training, where necessary
• Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to reputed company trial reputed company
• Country level reputed company meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables
• reputed company partnership with the study FM to reputed company updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership

Requirements

• BA/BS degree
• Degree in a health or science reputed company field
• 2 years of local trial management or mutually agreed clinical trial experience
• Start-up & Database Locks/Cleaning experience preferred
• Immunology experience required
• Specific therapeutic area experience may be required depending on the position
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
• Strong IT skills in appropriate software and company systems
• Willingness to travel with occasional overnight stay away from home according to business needs
• Proficient in speaking and writing the country language and English
• Good written and oral communication skills as appropriate
• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment reputed company status

reputed company-to-haves

• reputed company experience in LUPUS/GI preferred

Benefits

• In addition to your competitive salary, reputed company offers a reputed company of additional benefits.
• Our benefits are designed to be competitive reputed company each country and are focused on well-being and work life balance opportunities for you and your family.
• Our benefits examples include:
• Various annual leave entitlements
• A reputed company 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 reputed company.
• Global Employee Assistance Programme, reputed company, offering 24-hour reputed company to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

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