Clinical Trial Manager II, IQVIA Biotech

About the Role

As a Clinical Trial Manager, the successful candidate will be responsible for ensuring clinical delivery of assigned projects, managing clinical risks, and contributing to the development of project risk mitigation plans. This is a full-time, home-based position that requires a strong understanding of clinical research, project management principles, and regulatory requirements.

The ideal candidate will have a bachelor's degree in a healthcare or scientific discipline and at least 5 years of experience in clinical research or a related field. Excellent communication and leadership skills are essential for success in this role, as the Clinical Trial Manager will be working closely with internal and external stakeholders to deliver projects and drive business growth.

What You Will Do

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements, customer requirements, and internal policies and procedures
• Manage clinical aspects of project finances, including Estimate at Completion (EAC), and identify opportunities for additional services or out-of-scope work
• Develop and implement clinical risk mitigation plans, and manage clinical risks throughout the project lifecycle
• Collaborate with clinical teams to support milestone achievements and report to internal and external stakeholders as required
• Manage clinical stakeholders, including site visits and communication with study sites
• Develop and present Clinical Operation plans in partnership with Business Development and Project Leadership
• Contribute to the development of clinical delivery strategies for proposals and participate in bid defense preparations and meetings
• Mentor and coach new team members to ensure a smooth transition and knowledge transfer
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks
• Identify and manage changes to baseline EAC and scope of work, and communicate effectively with stakeholders

What We Are Looking For

• Bachelor's degree in a healthcare or scientific discipline
• At least 5 years of experience in clinical research or a related field
• Basic knowledge of project management practices and terminology
• Good knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Broad protocol knowledge and therapeutic area expertise
• Excellent communication, leadership, and problem-solving skills
• Ability to work in a fast-paced, dynamic environment with multiple priorities and deadlines
• Strong analytical and strategic thinking skills, with the ability to analyze complex data and develop effective solutions
• Experience with clinical trial management systems and other relevant software applications

Nice to Have

• Experience with agile project management methodologies
• Certification in clinical research or a related field, such as CCRA or CCRC
• Knowledge of budgeting and financial management principles
• Experience with site management and clinical monitoring

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a leading biotech company and contribute to the development of innovative treatments
• Collaborative and dynamic work environment with a team of experienced professionals
• Professional development opportunities, including training and education programs
• Flexible work arrangements, including remote work options
• Access to cutting-edge technology and software applications
• Recognition and reward programs for outstanding performance
• Comprehensive health and wellness programs, including mental health support and employee assistance programs

• Develop a strong understanding of clinical research regulatory requirements, including GCP and ICH guidelines, to stand out in this role.
• Highlight your experience with clinical trial management systems and other relevant software applications in your resume and cover letter.
• Prepare examples of your leadership and problem-solving skills, as well as your ability to work in a fast-paced environment with multiple priorities and deadlines.
• Research IQVIA Biotech and the biotech industry to demonstrate your knowledge and interest in the field.
• Be prepared to discuss your experience with budgeting and financial management, as well as your ability to analyze complex data and develop effective solutions.
• Consider obtaining a certification in clinical research or a related field to demonstrate your expertise and commitment to the profession.
• Develop a strong network of professionals in the industry, including attendance at industry events and conferences, to stay up-to-date on the latest developments and best practices.