Study Manager

Study Manager - Remote

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Study Manager at ICON, you will work cross -functionally within internal and external partners (e.g. vendors) to deliver delegated operational tasks from Initiation until study archiving to time, quality, budget, company standards.

What You Will Do:

In this role you will work in close partnership with the Global PM and Global Study Managers on end-to-end operational study delivery activities, from study setup to study archival.


Key responsibilities include:

• Oversight of Project Specialists activities and ensuring completeness of internal systems/databases/tracing tools and project plans.

• You will work cross functionally, with internal and external team members, in accordance with STOM framework, current clinical study regulations and procedures, policies and systems throughout the life cycle of the study.

• Monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study

• Facilitating and maintaining interactions and meetings with internal and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies

• support GSM in CRO oversight, overseeing study-specific deliverables, ensuring continued monitoring
  and timely delivery of activities delegated to third parties

• vendor management

• country oversight

• coordinating study-related activities and overseeing study team's communication – meetings, info-spaces, newsletters, action logs, communication plans, team lists

• overseeing delivery of clinical supplies, investigational products and all study materials

• data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness

• Overseeing of budget tracking – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Global PM. 
   

Your Profile:

You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.

• Knowledge of clinical trials, drug development process. 

• Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.

• Experience in using Trial Master File industry accepted standard. 

• Project management skills (preferably with analytical/financial skills) and good leadership skills.

• Excellent verbal and written communication in English. 

• Proven experience in clinical operations and/or study management is required

• Strong communication and relationship building skills, including external service provider management skill

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply