Study Manager - Vaccine

Syneos Health/ inVentiv Health Commercial LLC; North Carolina; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Company car/allowance

Health benefits

401k matching

Stock purchase plan

Bonus eligibility

Flexible PTO / Sick time

Job summary

Syneos Health is seeking a Study Manager – Vaccine to lead interdisciplinary clinical research studies in a fast-paced environment. You will oversee project teams, ensure timelines, budgets, and quality, and maintain regulatory compliance (GCP/ICH) across all study conduct activities.

As primary liaison to clients, you will prepare management reports, present at meetings, and help drive contingency plans and risk mitigation.

Qualifications

• CRO experience and regulatory knowledge (GCP/ICH).
• Strong organizational skills and ability to work independently.
• Direct therapeutic area expertise.
• Excellent communication and presentation abilities.
• Willingness to travel approximately 25%.

Responsibilities

• Lead project teams to ensure quality, timelines and budget management.
• Serve as liaison between company and customer for timely study launch and closeout.
• Ensure studies meet GCP, SOPs and regulatory requirements.
• Maintain TMF quality and study information across databases.
• Prepare management reports for clients and management.
• Develop contingency planning and risk mitigation strategies.
• Build relationships to generate future business and possibly participate in bid defenses.
• May line-manage other PMs and clinical monitoring staff.

Skills

Project management

Communication

Time management

Interpersonal skills

Leadership

Education

Bachelor's degree in life sciences or related

Job description

Study Manager - Vaccine

Job Responsibilities

• Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP's, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
• 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.
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develops strong 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) level of qualification 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%).

Benefits

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/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, 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.

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.