Clinical Trial Manager II

Clinical Trial Manager II

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 work streams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:

• Collaborate with cross-functional teams to design and implement effective clinical trial enrollment and 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, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Study Demographic and Diversity Plan, Vendors Oversight Plan, Results Dissemination Plan, Investigator/CRA Meeting Set Up & associated training, Expected Document List, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Patient Engagement Activities, CSDD KOM & template, Safety Management plan, Protocol Deviation Management Plan, eTMF & vendor set-up, 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%)