FSP Clinical Trial Manager I/ II (Melbourne office based)

Description

FSP Clinical Trial Manager I/ II (Melbourne office based)

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.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed
• Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines
• Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination
• Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation
• Track study progress and ensure alignment with project milestones, client deliverables, and budget, providing regular updates to stakeholders
• Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress
• Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates
• Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment
• Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions
• Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability

Qualifications:

• Bachelor's degree in a related field (e.g., life sciences, clinical research)
• Minimum of 3 years of experience in clinical trial management or a related field
• In-depth knowledge of clinical research processes and regulations
• Strong project management and organizational skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Proficiency in using clinical trial management software and tools

We are always excited to connect with great talent. This posting is intended for a potential upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

Certifications:

• Certified Clinical Research Professional (CCRP) or equivalent certification preferred

Necessary Skills:

• Strong analytical and problem-solving skills
• Attention to detail and accuracy
• Ability to manage multiple projects and priorities simultaneously
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

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.

Summary

Roles within the Clinical Trial Management job family at the P22 level are responsible for overseeing the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities. Individuals in these roles collaborate closely with the principal investigator, serve as liaisons between research subjects, client teams, investigators, and clinic operations teams, and meticulously plan logistics and resource usage. These roles require tracking study progress in alignment with project milestones, client deliverables, and budget, while ensuring compliance with applicable regulations globally and by region.Impact and ContributionRoles within the Clinical Trial Management job family at the P22 level significantly impact the success of clinical trials by ensuring that all aspects of the study are meticulously planned and executed. Individuals in these roles contribute to the design, implementation, and delivery of processes, programs, and policies, leveraging their in-depth knowledge and skills within the professional discipline. By managing processes and potentially directing the work of lower-level professionals, these roles ensure that clinical trials are conducted efficiently and effectively, ultimately contributing to the advancement of medical research and the development of new treatments.Core Focus•Overseeing the development and coordination of Phase 1 clinical research studies•Collaborating with principal investigators and serving as liaisons between various stakeholders•Planning logistics and resource usage for clinical trials•Tracking study progress in alignment with project milestones, client deliverables, and budget•Ensuring compliance with global and regional regulations•Contributing to the design, implementation, and delivery of processes, programs, and policies•Managing processes and potentially directing the work of lower-level professionals