Ref #: 29576

Employment type: Permanent - Full-Time

Location: Berkshire

Posted: 14-Oct-2021


ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

We are hiring an experienced senior study manager to join our Early Development Study team.

As a Global Early Phase clinical manager, you will drive the management of operational activities related to planning, implementing, executing, and reporting of clinical trials. You will be a core member of the Evidence Generation Team

The role:
Operations Planning & Execution
• Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products
• Develops the strategic scenarios of designs for early phase clinical development plan as part of the EGP generation

Study Oversight & Execution
• Leads, manages, and monitors overall study related activities including:
o Issues related to patient eligibility, enrollment and protocol deviations
o Ongoing safety data review and completion of study data collection, data lock, and analysis
o Resolution of cross-functional study-specific issues
o Communication of study status to key stakeholder and updating relevant systems
o Ensures study personnel are appropriately trained and understand study timelines and deliverables
o 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

To be successful in the role, you will have:
• Early development study management experience, ideally a minimum of 4 to 5 years
• Advance knowledge of first in human 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 deliverables, budgets, and timelines
• Time, cost and quality metrics
• Key performance indicators (KPIs)
• Ideally MS, RN, or PharmD degree
• 7+ years of experience in a life sciences or medically related field, ideally gained within CRO, pharma or biotech
• Management experience of direct reports
• Experience in the oversight of Functional Service Providers, outside vendors (CROs, central labs, imaging vendors, etc.)
• Valid, current UK working eligibility

What is Offered

• Full-time homebased role
• Salary will be offered depending on level of experience and skills
• Permanent contract of employment with company perks and benefits
• Company benefits to include 25 days annual leave plus UK bank holidays, car allowance, bonus as well as pension, medical health insurance, etc.

Please contact me for more details at

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.