Study Manager - Respiratory

About Syneos Health

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 places the customer and the patient at the center of everything we do.

We are continuously looking 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 will 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.

Over the past five 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 will take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Our Culture

We are committed to our "Total Self" culture, where you can authentically be yourself. This culture unites us globally, and we are dedicated to taking care of our people. We are passionate about developing our people through career development, supportive line management, technical training, and peer recognition.

We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong. At Syneos Health, we believe in providing an environment where our people can thrive, develop, and advance.

About the Role

As a Study Manager - Respiratory, you will serve as a primary liaison between the Company and the Customer, ensuring timely study launch, conduct, and closeout according to contractual agreements. You will manage a project as a project manager, overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements.

In this role, you will lead the project team to ensure quality, timelines, and budget management. You will be accountable for the financial performance of each project, coordinating activities and deliverables of all study conduct partners while proactively identifying and managing issues. You will also be responsible for the quality and completeness of the Trial Master File (TMF), maintaining study information on various databases, and ensuring inspection readiness for all aspects of study conduct.

You will plan, coordinate, and present at internal and external meetings, preparing project management reports for clients and management. Additionally, you will develop contingency planning and risk mitigation strategies to ensure the successful delivery of study goals and may participate in bid defense meetings as a potential project manager.

Hiring Process & Application

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

Equal Opportunity

Syneos Health is committed to compliance with all applicable federal, state, and municipal regulations, including the implementation of the EU Equality Directive and the Americans with Disabilities Act. We provide reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job. We consider qualified applicants regardless of background.