Study Manager - Ophthalmology

Syneos Health; United States; Remote; USD 95,000 - 150,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, Vis

401k match

Employee Stock Purchase Plan

Commissions/bonus

Flexible PTO and sick time

Job summary

Syneos Health in the United States is seeking a Study Manager - Ophthalmology to lead interdisciplinary clinical research studies, ensure GCP compliance, and manage timelines and budgets.

You will serve as primary liaison with customers, drive study execution from start to closeout, and help maintain TMF quality while building strong client relationships.

This role offers comprehensive benefits, opportunities for professional growth, and travel obligations around 25%.

Qualifications

• Bachelor’s Degree or equivalent in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
• Clinical research organization (CRO) experience and knowledge of GCP guidelines and regulatory requirements.
• Strong organizational skills and ability to manage time and work independently.
• Direct therapeutic area expertise is preferred.
• Ability to embrace new technologies and effective communication skills.
• Travel willingness approx. 25%.

Responsibilities

• Project Leadership and Delivery: Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, 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 agreements.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project and coordinate activities of study conduct partners and mitigate issues.
• Ensure studies are conducted in compliance with GCP and regulatory requirements; accountable for all project deliverables.
• Responsible for TMF quality and completeness for assigned projects.
• Maintain study information on various databases and systems.
• Oversee study management components for inspection readiness and project plans.
• Plan, coordinate and present at internal and external meetings; prepare project management reports.
• Develop contingency planning and risk mitigation strategies for successful delivery.
• Develops strong client relationships to generate new/add-on business.
• May participate in bid defense meetings and line manage other PM staff.

Skills

CRO experience

GCP knowledge

Communication skills

Time management

Organizational skills

Therapeutic area expertise

Willingness to travel

Independent working

Education

Bachelor’s Degree or equivalent in life sciences or related field

Job description

Study Manager - Ophthalmology

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

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. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

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%).

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.

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. Learn more about Syneos Health.

http://www.syneoshealth.com

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.