Project Manager II/ Senior Project Manager (Early phase experience required)
Updated: Yesterday
Location: AUS-Remote
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Description
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 we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and 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 about changing lives.
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. We achieve this by embracing diversity of thoughts, backgrounds, cultures, and perspectives – creating a place where everyone feels they belong.
Job Responsibilities
- Project Leadership and Delivery. Manage a project as a project manager overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOP’s, and regulatory requirements.
- Act as the primary liaison between the company and the customer to ensure timely study launch, conduct, and closeout according to contractual agreements.
- Lead project team to ensure quality, timelines and budget management.
- Accountable for the financial performance of each project. Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. Accountable for all project deliverables for each project assigned.
- Responsible for quality and completeness of TMF for assigned projects.
- Accountable for maintenance of study information on a variety of databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans.
- Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management.
- Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Develop solid relationships with current clients to generate new and/or add‑on business for the future.
- May participate in bid defense meetings where presented as potential project manager.
- May be required to line‑manage other project management team members and clinical monitoring staff.
Qualifications
- Bachelor’s Degree (or equivalent) in life sciences, medicine, pharmacy, nursing, or a comparable combination of education and experience.
- Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
- Strong organizational skills.
- Strong ability to manage time and work independently.
- Direct therapeutic area expertise.
- Ability to embrace new technologies.
- Excellent communication, presentation and interpersonal skills, both written and spoken.
- Ability to travel as necessary (approximately 25%).
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.
Summary
Roles within the Clinical Project Management job family are responsible for planning, directing, creating and communicating clinical study timelines. They gather input from cross‑functional teams and create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study processes across trials, oversee and resolve operational aspects of trials in conjunction with project teams and in accordance with SOPs, GCP, and specific country regulations such as site and vendor selection. They prepare budgets, ensure studies are conducted within protocols, monitor progress, and follow up when issues develop. They implement the clinical development strategy and may develop trial recruitment strategies. Key impact includes providing strategic vision and tactical direction across disciplines and organizations, managing process, policy and performance, and supervising employees. They deliver operational results with moderate impact on immediate achievement of results for the team.
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway.
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Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at:
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