Senior Clinical Trial Associate

Senior Clinical Trial Associate

SCYNEXIS - 4.5

Jersey City, NJ Job Details Full-time $88,000 - $105,000 a year 16 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Retirement plan Qualifications Document review (document control) Content editing Administrative experience ICH guidelines Bachelor's degree Attention to detail Organizational skills FDA regulations Full Job Description SCYNEXIS, Inc. (

NASDAQ:

SCYX) is a publicly traded biotechnology company dedicated to advancing innovative solutions for severe rare diseases. Our new asset, SCY-770 is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and has been granted Orphan Drug designation. SCYNEXIS's proprietary antifungal platform "fungerps" includes

BREXAFEMME

® (ibrexafungerp tablets), the first approved representative of this novel class, which has been licensed to GSK, and SCY-247 which is currently in a Phase 1 stage of development.

Position Summary:

The Senior Clinical Trial Associate (Sr. CTA) provides administrative and operational support to clinical study teams responsible for the execution of clinical trials and may support multiple studies concurrently. The Sr. CTA supports both internally managed studies and studies outsourced to Clinical Research Organizations (CROs) and other third-party vendors, receiving assignments from the Head of Clinical Operations. This role reports to the Senior Clinical Study Manager.

Responsibilities:

Organize and deliver analyzable reports and metrics to the Clinical Study Manager (CSM). Schedule and coordinate clinical study team and study-related meetings, including preparation of agendas, presentation materials, and meeting minutes. Prepare data and supporting materials for study assessments such as feasibility and site selection. Contribute to the review of study documents, including informed consent forms, case report forms, study manuals, and procedures; facilitate document review workflows. Prepare materials for study training and investigator meetings. Track Key Performance Indicators (KPIs), including site activation, enrollment, and site management activities to projected plans, and proactively escalate risks to the CSM. Review monitoring reports as assigned by the CSM. Directly communicate with CRO and vendors counterparts. Utilize Electronic Data Capture (EDC) systems to support accurate and efficient clinical data management activities. Create, maintain, and organize study and project files. Perform quality checks of the Trial Master File (TMF), including reconciliation of expected documents and follow up on deficiencies to resolution. Create and maintain study trackers (e.g. Investigator and Site Lists, study approvals) as assigned by the CSM. Maintain and organize key study documents within the company's internal document repository. Provide guidance and subject-matter expertise within purview to junior team members.

Requirements and Preferred Skills:

Bachelor's degree with 5+ years of relevant experience, in a pharmaceutical and/or CRO environment Excellent written and verbal communication skills Demonstrated ability to manage multiple projects and timelines simultaneously Strong organizational skills with exceptional attention to detail Proven document proofreading, editing, and review capabilities Ability to work independently, think critically, proactively communicate meaningful and timely updates, and contribute effectively in team meetings Basic knowledge of drug development, ICH GCP guidelines, and FDA regulations Familiarity with the DIA TMF Reference Model preferred Strong proficiency with Microsoft 365 applications Occasional travel may be required (5-10%)

SCYNEXIS

is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. The starting pay for this role is between $88,000.00 and $105,000.00. The estimated salary range represents an anticipated range for this position. The actual base salary offered may vary based on a variety of factors. We offer a competitive total rewards package that includes short-term and long-term incentive programs and a comprehensive benefits package, including medical, dental, and vision coverage, a 401(k) with company match, paid time off, and additional benefits.

Pay:

$88,000.00 - $105,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Retirement plan Vision insurance

Work Location:

Hybrid remote in Jersey City, NJ 07302