Clinical Trial Lead

What you will be doing:

• 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

Your profile:

• 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

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