Syneos Health

Description

(Expression of Interest) Project Manager II/ Senior Project Manager- Vaccines experience required (Home- Based Australia)

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

• Plan, direct, create, and communicate clinical study timelines to ensure deliverables are produced on schedule. This includes developing detailed project plans, setting milestones, and coordinating with cross-functional teams to ensure timely completion of tasks
• Gather input from cross-functional teams to create comprehensive plans for clinical studies. This involves collaborating with departments such as regulatory affairs, data management, and clinical operations to integrate their feedback into the study plans
• Ensure consistency of clinical study processes across clinical trials, adhering to standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. This includes developing and implementing standardized processes and procedures to ensure uniformity across all trials
• Oversee and resolve operational aspects of clinical trials in conjunction with project teams. This includes identifying and addressing any issues that arise during the trial, coordinating with team members to implement solutions, and ensuring that the trial stays on track
• Select sites and vendors, prepare clinical trial budgets, and ensure studies are conducted within clinical trial protocols. This involves evaluating potential sites and vendors, negotiating contracts, and managing budgets to ensure that the trial is conducted within the allocated resources
• Monitor progress and follow up with team members and line managers when issues develop. This includes tracking the progress of the trial, identifying any deviations from the plan, and working with team members to address any issues that arise
• Implement and prepare the clinical development strategy as outlined by the clinical teams. This involves developing and executing strategies to achieve the clinical development goals, coordinating with clinical teams to ensure alignment, and monitoring progress towards these goals
• Develop trial recruitment strategies to ensure successful participant enrollment. This includes identifying target populations, developing recruitment plans, and implementing strategies to attract and retain participants

Qualifications:

• Bachelor's degree in a related field (e.g., Clinical Research, Life Sciences, Healthcare Management)
• Minimum of 5 years of experience in clinical project management or a related role
• Proven track record of successfully managing clinical trials and ensuring adherence to SOP, GCP, and country regulations

Certifications:

• Certification in Clinical Research (e.g., CCRP, CCRA) is preferred
• Project Management Professional (PMP) certification is a plus

Necessary Skills:

• Strong organizational and planning skills to create and manage clinical study timelines
• Excellent communication skills to gather input from cross-functional teams and communicate plans effectively
• Ability to oversee and resolve operational aspects of clinical trials
• Knowledge of SOP, GCP, and country regulations to ensure consistency across clinical studies
• Experience in site and vendor selection, budget preparation, and monitoring progress
• Ability to implement and prepare clinical development strategies
• Strong problem-solving skills to address issues that arise during clinical trials

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 Clinical Project Management job family at the M23 level are responsible for planning, directing, creating, and communicating clinical study timelines. These roles gather input from cross-functional teams to create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. Responsibilities include site and vendor selection, preparing clinical trial budgets, and ensuring studies are conducted within clinical trial protocols. These roles also involve monitoring progress and following up with team members and line managers when issues develop. Additionally, they implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies. Impact and Contribution Roles within Clinical Project Management job family at the M23 level significantly impact the success of clinical trials by ensuring that all aspects of the study are conducted efficiently and effectively. By gathering input from cross-functional teams and creating detailed plans, these roles help ensure that deliverables are produced on schedule, contributing to the overall success of the clinical trials. Their oversight of operational aspects of clinical trials ensures consistency and adherence to SOP, GCP, and country regulations, which is crucial for the integrity and reliability of the study results. Additionally, their involvement in site and vendor selection, budget preparation, and monitoring progress helps maintain the smooth operation of clinical trials, ultimately contributing to the advancement of clinical research and development. Core Focus • Planning, directing, creating, and communicating clinical study timelines • Overseeing operational aspects of clinical trials • Ensuring consistency across clinical studies • Adhering to SOP, GCP, and country regulations • Selecting sites and vendors • Preparing clinical trial budgets • Monitoring progress and following up with team members and line managers • Implementing and preparing the clinical development strategy • Developing trial recruitment strategies