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Form of workAs a Global Early Clinical Development Manager you will play a key role in improving the lives of patients by accelerating the development of our customers ' drugs and devices through innovative solutions. You will be a dedicated resource to one of our clients, embedded in their working environment, systems, and processes.
Responsibilities
What you will be doing:
- Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
- Develops the strategic scenarios of designs for early phase Clinical Development plan
- 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
- 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 analysis
- 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 of 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
Qualifications
You are:
- Education: BA/BS/BSc or RN
- At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
- Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
- Strong clinical project management skills and experience in driving milestones.
- Excellent communication and interpersonal skills to effectively work with cross-functional teams.
- Proficient in trial management systems and MS Project (or equivalent PM software).
- Knowledge of ICH/GCP and regulatory guidelines/directives
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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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Employment Type: OTHER
