Study Manager - Vaccine

Syneos Health, Inc.; Morrisville (NC); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health benefits (medical, dental, vision)

401k company match

Flexible paid time off (PTO)

Job summary

Syneos Health, Inc., located in Morrisville, NC, is seeking a Project Manager for interdisciplinary clinical research studies. The role involves ensuring compliance with regulatory standards and acting as the primary liaison between the company and clients.

Successful candidates will have a Bachelor’s degree in life sciences and strong project management skills, contributing to the goals of the clinical project management team.

Benefits include health coverage, a 401k match, and flexible paid time off.

Qualifications

• Minimum 3 years of project management experience in clinical research.
• Strong knowledge of Good Clinical Practice/ICH guidelines.
• Ability to travel up to 25%.

Responsibilities

• Manage interdisciplinary clinical research studies as a project manager.
• Act as primary liaison between the Company and the Customer.
• Ensure compliance with GCP, SOPs, and regulatory requirements.

Skills

Strong organizational skills

Excellent communication skills

Ability to manage time independently

Direct therapeutic area expertise

Ability to embrace new technologies

Education

Bachelor’s Degree in life sciences, Medicine, Pharmacy, Nursing

Job description

Updated: Yesterday
Location: Morrisville, NC, United States
Job ID: 25108971

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

Job Responsibilities

• 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.

Qualifications

• 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.

Salary Range

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 qualifications, skills, competencies, and proficiency for the role.

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 and processes across clinical trials and oversee operational aspects of clinical trials in conjunction with project teams and in accordance with SOPs, GCP and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Studies are conducted within protocols, monitoring progress and following up with team members and line managers when issues develop. They implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies. Impact and contribution include providing strategic vision and tactical direction across a discipline and/or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and directing employees. Goals are achieved through process, policy, and performance management of direct and/or indirect reports. They supervise experienced support employees and entry individual contributors and deliver operational results that moderately impact immediate team achievements. They possess broad job knowledge in operational, administrative and specialized fields and adapt new procedures, techniques, tools, etc. They understand basic management approaches such as work scheduling, prioritizing, coaching and process execution.

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.