Senior Clinical Trial Manager

Overview

Senior Clinical Trial Manager (Sponsor dedicated) – Location: Adelaide, SA, Australia. Job ID: 25101543

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Responsibilities

• Oversee the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities, ensuring that all aspects of the trial are conducted efficiently and effectively
• Collaborate with principal investigators, research subjects, client teams, investigators, and clinic operations teams to facilitate communication and coordination, ensuring that all parties are aligned and informed throughout the trial process
• Plan logistics and resource usage for clinical trials, including the allocation of staff, equipment, and materials, to ensure that trials are conducted smoothly and without delays
• Track study progress in alignment with project milestones, client deliverables, and budget, using project management tools and techniques to monitor and report on the status of the trial
• Ensure compliance with applicable regulations globally and by region, including adherence to Good Clinical Practice (GCP) guidelines, ethical standards, and regulatory requirements, to maintain the integrity and quality of the trial
• Manage a team of individual contributors and supervisors, providing strategic vision and tactical direction, setting goals and objectives, and monitoring performance to ensure that the team operates effectively and achieves its targets
• Deliver operational results that have direct impact on immediate or short-term department outcomes, using data-driven decision-making and problem-solving skills to address challenges and optimize trial performance
• Provide in-depth knowledge and skills within the scientific/technology or professional discipline, understanding the impact of work on related areas, and leveraging expertise to contribute to the advancement of the organization's research objectives
• Utilize practical knowledge in managing the execution of processes, projects, and tactics within the team, ensuring that all activities are conducted in accordance with established protocols and procedures

Qualifications

• Bachelor's degree in a relevant scientific or healthcare field; advanced degree preferred
• Minimum of 5 years of experience in clinical trial management, with a focus on Phase 1 studies
• Proven track record of managing clinical trials and delivering successful outcomes
• Strong understanding of global and regional regulations related to clinical research
• Excellent organizational, planning, and resource management skills
• Ability to lead and manage a team, providing strategic vision and tactical direction

Certifications

• Certified Clinical Research Professional (CCRP) or equivalent certification preferred
• Project Management Professional (PMP) certification is a plus

Necessary Skills

• In-depth knowledge of clinical trial processes and regulations
• Strong leadership and team management skills
• Excellent communication and collaboration abilities
• Proficiency in project management and resource planning
• Ability to analyze and interpret complex data
• Strong problem-solving and decision-making skills

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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