ICON Strategic Solutions · 10 hours ago
Clinical Trial Lead (Clinical Project Manager)
United States
Full-time
Remote
Mid, Senior Level
$134K/yr - $167K/yr
3+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. The Clinical Trial Lead will manage the day-to-day operations of assigned trials, ensuring compliance with regulatory requirements and leading cross-functional teams to achieve project goals.
Pharmaceuticals
Responsibilities
Manage and lead the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities
Responsible for oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies
Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
Lead or oversee development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data
Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally
Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally
Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team
Lead feasibility assessment and selection of countries and sites for trial conduct
Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables
Participates in and/or facilitates cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals
Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders
Participates in inspection readiness activities including coordination of clinical study team deliverables
Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable
Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy
Facilitate and manage regional KOL interactions, as applicable
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings
Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct
Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate
Responsible for the preparation and management of budgets, timelines and resources for assigned clinical trials
Qualification
Required
BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring with a focus on cross-functional team oversight
Requires proven project management skills and trial leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
Phase I oncology experience required
Global experience required (Experience working with China preferred)
Must be open to working PST time as required
Moderate (~25%) travel required
Benefits
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, TELUS Health, offering 24-hour access 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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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