Clinical Trial Manager II

IRE; Poland; On-site; PLN 261,000 - 392,000; Full time

Benefits offered by this job

Health and wellbeing programs

Retirement and pension plans

Life assurance and disability coverage

Learning and development opportunities

Job summary

ICON is a global healthcare intelligence and clinical research organisation uniting teams to bring new medicines to patients faster. The Clinical Trial Manager II role covers Bulgaria, Romania, Poland, Spain, Czech Republic and Hungary, shaping trial design, execution and data interpretation.

You will manage trial workstreams, ensure regulatory compliance and quality, coordinate with cross-functional teams, monitor budgets, and communicate with stakeholders while traveling up to 25%.

Qualifications

• Bachelor's degree in life sciences or related discipline; strong understanding of regulatory processes.
• At least 5+ years of relevant study management experience in a pharmaceutical/scientific environment.
• Strong skills in project management and use of associated tools; deep knowledge of GCPs and ICH guidelines.
• Experience in clinical research: study management, monitoring, data management.
• Leadership abilities to motivate and empower teams to achieve objectives.
• Excellent communication and collaboration across global teams.
• Detail-oriented with ability to manage multiple priorities.
• Willingness to travel approximately 25%.

Responsibilities

• Oversee clinical trial management workstreams and ensure deliverables meet quality and timeline expectations.
• Collaborate with cross-functional teams to design and implement trial protocols.
• Manage day-to-day trial operations ensuring regulatory compliance.
• Analyze and interpret trial data to identify trends and optimize outcomes.
• Proactively address challenges to ensure successful trial execution.
• Communicate with stakeholders to foster partnerships and smooth processes.
• Manage study budgets and related activities.

Skills

Clinical trial management

Project management

Leadership

Regulatory knowledge

Cross-functional collaboration

Communication skills

Detail oriented

Budget management

Education

Bachelor's degree in life sciences

Job description

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

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 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

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.