Ref #: 33791

Employment type: Permanent - Full-Time

Location: US - Nationwide (home-based)

Posted: 30-Nov-2021


Global Early Clinical Development Manager

If you have experience in Clinical Pharmacology, Phase 1 Dose Finding/Expansion, Digital/Mobile Health and Technology Evaluation and strong clinical trial management experience for early phase development, this is a great home-based opportunity.

Key Purpose

• Drives the management of operational activities related to planning, implementing, executing, and reporting of clinical trials
• Member of one or more cross-functional clinical study teams
• Core member of the Evidence Generation Team
Key Activities

Operations Planning & Execution
• Leads the study level planning and execution of overall operational deliverables, including study
level forecast of investigational products and study logistics plan through the CST ITL
• Develops the strategic scenarios of designs for early phase clinical development plan as part of the EGP generation
• Ensures standard processes, tools, and procedures are used consistently
• Routine engagement with Clinical Investigators
• Provide oversight, support the design, and manage operational activities related to the planning,
implementation, and reporting of outsourced Clinical Pharmacology studies

Study Oversight & Execution
• Leads, manages, and monitors overall study related activities including:
– Issues related to patient eligibility, enrollment and protocol deviations
– Ongoing safety data review and completion of study data collection, data lock, and
– Resolution of cross-functional study-specific issues
– Communication of study status to key stakeholder and updating relevant systems
– Ensures study personnel are appropriately trained and understand study timelines
and deliverables
– Manages study budget & communication of budget changes
• Drives the writing and/or review study design, synopsis, protocols, supplements, amendments and Investigational Product Instructional Manuals (IPIM)
• Contributes operational input to:
– Study related documentation, including safety and regulatory documents, Clinical
Study Reports, Case Report Forms, and other study-related documents
• Identifies site selection and feasibility in partnership with the Dev. Feasibility Manager
• Assists in selection, set up, and management of vendors, including invoice approval
• Organizes and leads investigator meetings where appropriate
• Drives and coordinates Dose Level Review Meetings (DLRMs) and ensures decisions are
effectively communicated, documented, and implemented
Inspection Readiness
• Supports internal & external audit and inspection activities and contributes to CAPAs globally
• Ensures study is inspection ready and executes related activities (e.g., TMF review, study history

Preferred Qualifications

• MS, RN, or PharmD Degree
• 7+ years of experience in life sciences or medically related field
• 4+ years of bio-pharmaceutical clinical research experience obtained working on industry sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company
• Management experience of direct reports
• Experience in oversight of Functional Service Providers, outside vendors (CRO’s, central labs,
imaging vendors, etc.)


• Advanced knowledge of first in human trials and early development study strategy & management
• Clinical trial processes and operations
• Extensive knowledge of ICH/GCP regulations and guidelines
• Project and Program management including oversight of study deliverable, budgets and timelines
• Time, cost and quality metrics, Key performance indicators (KPIs)
• Relevant Therapeutic knowledge


• Matrix team leadership
• Project Management
• Problem solving
• Decision making
• Delegation skills
• Relationship Management and influencing skills
• Oral and written communication
• Time management
• Organizational and planning skills
• Ability to work effectively in a team/matrix environment on multiple projects
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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

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