Study Manager - Vaccine

Updated: Yesterday
Location: Morrisville, NC, United States
Job :

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

• Project Leadership and Delivery – manage projects as a project manager overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements.
• Act as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout in accordance with the Contractual agreement.
• Lead project team to ensure quality, timelines, and budget management.
• Accountable for the financial performance of each project and proactively identify and manage issues.
• Ensure studies are conducted in compliance with regulations and that all project deliverables are met.
• Responsible for quality and completeness of TMF for assigned projects.
• Maintain study information on a variety of databases and systems.
• Ensure inspection readiness and oversight for development and implementation of project plans.
• Plan, coordinate, and present at internal and external meetings and prepare project management reports for clients and management.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develop strong relationships with current clients to generate new and/or add‑on business.
• Participate in bid defense meetings as potential project manager.
• Line‑manage other project management team members and clinical monitoring staff, as required.

• Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or equivalent 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, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. Expressing your interest will add you to our talent pipeline and you will be considered should this role become available.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality‑of‑life balance. The benefits for this position may include a company car or car allowance; health benefits to include medical, dental and vision; company match 401k; eligibility to participate in employee stock purchase plan;

eligibility to earn commissions/bonuses based on company and individual performance; and flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s…