Associate, Clinical Trials

Zydus Therapeutics Inc. • Hopewell Township, NJ

2d • Onsite

About The Position

Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow.

Requirements

• Experience collaborating and interacting with internal and external partners from a variety of cultural backgrounds and geographic locations. (Although note require, familiarity with other languages will be noted.)
• Proficient with Windows Office (Word, Excel, and PowerPoint) and Adobe Acrobat.
• Excel will be used extensively. Experience with chart development and basic functions are necessary.
• Must be well-organized.
• Must have excellent verbal and written skills.
• Fluent in English.
• Some measure of flexibility will be necessary. Due to the international framework of the organization, there will be instances wherein meetings are scheduled during non-traditional workday hours. This usually occurs no more than 2 hours prior to the standard workday.
• The ideal candidate must be able to work independently but consistently.
• Personal interactions are critical to the role. Must have good relationship skills.

Responsibilities

• Trial Master File maintenance, auditing, and reconciliation experience.
• Serve as the primary responsible party for the management of a Trial Master File (TMF).
• Archival of paper files and, if possible, experience auditing archived files.
• Meeting agenda and minute-taking experience.
• Review and manage Electronic and safety data management systems
• Partner with others to work on international clinical trials.
• Interact with institutional review boards (IRB).
• SOP development.
• Calendar management
• Expense report completion.
• An understanding of the regulatory requirements in the United States, as they pertain to essential documents and SOPs.
• Interacting with investigational sites.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree