Clinical Trial Manager II

Clinical Trial Manager II - Bulgaria, Romania, Poland, Spain, Czech Republic, Hungary - Sponsor Dedicated - Global Study Management Experience is required

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Clinical Trial Manager II at ICON, you will design and analyze clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies for one of our sponsor´s studies.

What You Will Do:

You will oversee clinical trial management workstreams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:

• Collaborate with cross-functional teams to design and implement effective clinical trial enrollment Collaborating with cross-functional teams to develop and implement comprehensive clinical trial protocols.
• Overseeing and managing the day-to-day operations of clinical trials, ensuring compliance with regulatory standards.
• Analyzing and interpreting clinical trial data, identifying trends, and providing insights to optimize study outcomes.
• Proactively addressing challenges and implementing effective solutions to ensure the successful execution of clinical trials.
• Communicating effectively with internal and external stakeholders to foster strong partnerships and facilitate smooth trial processes.
• Accountable for the following deliverables: Study Initiation Meeting 
  o Clinical Study Activity Plan 
  o Study Delivery Plan 
  o TMF Quality Strategy Document 
  o DCT Set Up 
  o Study Demographic and Diversity Plan 
  o Vendors Oversight Plan 
  o Results Dissemination Plan 
  o Investigator/CRA Meeting Set Up & associated training 
  o Expected Document List 
  o Recruitment Tracking 
  o Budget tracking eTMF filing and Vendor Set Up and Management 
  o Patient Engagement Activities 
  o CSDD KOM & template 
  o Safety Management plan 
  o Protocol Deviation Management Plan 
  o eTMF & vendor set-up 
  o Pharmacy Manual 
• Ensures compliance with ICH/GCP guidelines, all applicable laws and regulations, and company's SOPs for assigned studies. understand study contribution to program/submission.
• Ensures appropriate stakeholder communication, including study status, expectations, risks and issues.
• Accountable to operate within the study budget

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:

• Bachelor's degree in life sciences or related discipline. The role will require a good understanding of complex clinical development and regulatory processes.
• At least 5+ years of relevant study management experience in a 
  pharmaceutical/scientific environment.
• Strong skills and experience in project management and tools. In-depth 
  knowledge of GCPs and ICH guidelines
• In-depth experience in clinical research: study management, monitoring, data management.
• Strong performer / executor of operational tasks with strong skills and experience in study delivery.
• Experience of working across multiple types of study designs.
• Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Effective communication and interpersonal skills, with the ability to collaborate across diverse global teams.
• Detail-oriented and organized, with a track record of successfully managing multiple tasks and priorities simultaneously.
• Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available) 
• Willingness to travel as required (approximately 25%)

#LI-SK1

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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