
Fsp Clinical Trial Manager I/ Ii
2 days ago
**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.
**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
- 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.
**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. Fur
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