Study Manager - Ophthalmology

Syneos Health/ inVentiv Health Commercial LLC; North Carolina; On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health benefits (medical, dental, vision)

401(k) company match

Flexible paid time off

Job summary

Syneos Health/ inVentiv Health Commercial LLC is looking for a Study Manager in North Carolina to lead clinical research studies in ophthalmology with a focus on project management and compliance.

The ideal candidate will possess a Bachelor's degree and relevant experience in clinical research. This position includes benefits like health insurance and a 401(k) match, with flexible paid time off.

Qualifications

• CRO and relevant therapeutic experience preferred.
• Knowledge of Good Clinical Practice/ICH guidelines.
• Ability to manage time and work independently.

Responsibilities

• Manage interdisciplinary clinical research studies and ensure compliance with GCP.
• Act as primary liaison with the Customer for project management.
• Ensure quality, timelines, and budget management.

Skills

Strong organizational skills

Excellent communication skills

Ability to embrace new technologies

Direct therapeutic area expertise

Education

Bachelor's Degree in life sciences, Medicine, Pharmacy, or Nursing

Job description

Study Manager - Ophthalmology

We are looking for a Study Manager to provide project leadership and delivery for clinical research studies in ophthalmology.

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

The benefits for this position may include a company car or car allowance, health benefits to include medical, dental and vision, a company match 401(k), eligibility to participate in an 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.

EEO Statement

We are 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. The Company will determine what constitutes as equivalent to the qualifications described above. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Further, nothing contained herein should be construed to create an employment contract. All obligations are in line with EU Equality Directive and legislation of each country in which it operates.