Manager, Clinical Project

Zydus Therapeutics Inc.; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Zydus Therapeutics Inc. is seeking a Clinical Project Manager to provide comprehensive oversight and execution of deliverables for assigned clinical trial(s).

You will prepare and review study documents, organize meetings, ensure resources, manage vendor invoices, train clinical staff, lead study teams, monitor study conduct, and coordinate with Clinical Operations, Data Management, Medical Writing, QA, Legal, Finance and external partners to keep timelines and quality.

Qualifications

• Comprehensive oversight and execution of deliverables for assigned clinical trial(s).
• Prepare, oversee, and review documents that are related to assigned clinical study.
• Arrange or help in organizing clinical study meetings.
• Ensure the availability of necessary resources for the execution of clinical projects.
• Review and approve invoices being presented by study vendors and external consultants.
• Assist in the training and development of clinical staff as needed.
• Lead the clinical project team and various study team meetings.
• Oversee the pattern and manner in which the assigned clinical research study is being conducted.
• Fully involved in resolving issues; take part in procedure improvement initiatives.
• Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process.
• Coordinate with all functional teams within to ensure commitment to timeline and quality expectations, including Clinical Operations, Data Management, Medical Writing, Quality Assurance and Quality Control, Legal, Finance, and Senior Leadership, as well as external partners (CROs, Laboratories, Specialty service-providers, Investigators).
• Work hand-in-hand with clinical trial associates and document control personnel to manage documents that are related to the clinical study.

Responsibilities

• Oversee the execution of assigned clinical studies and ensure deliverables meet timelines and quality standards.
• Coordinate with cross-functional teams to align priorities and resolve conflicts.
• Manage study documents, vendor relationships, and invoices while supporting staff development.

Job description

Description

COMPANY SUMMARY

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. 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).

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.

The opportunity to empower people with the freedom to live healthier and more fulfilling lives is what makes a career with Zydus Therapeutics so rewarding. Our team is collaborative, innovative and adaptable. We are action-oriented and strive for excellence in all we do, all underpinned by respect, trust and integrity. We offer a wide variety of competitive benefits, services and support programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives

If you are passionate about helping bring potential life-changing discoveries to patients, then you share our mission.

Requirements

• Comprehensive oversight and execution of deliverables for assigned clinical trial(s).
• Prepare, oversee, and review documents that are related to assigned clinical study.
• Arrange or help in organizing clinical study meetings.
• Ensure the availability of necessary resources for the execution of clinical projects.
• Review and approve invoices being presented by study vendors and external consultants.
• Answerable to questions and issues raised by vendors and external consultants.
• Help in the training and development of clinical staff as needed.
• Lead the clinical project team and various study team meetings.
• Oversee the pattern and manner in which the assigned clinical research study is being conducted.
• Fully involved in resolving issues; take part in procedure improvement initiatives.
• Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process.
• Coordinate with all functional teams within to ensure commitment to timeline and quality expectations, including Clinical Operations, Data Management, Medical Writing, Quality Assurance and Quality Control, Legal, Finance, and Senior Leadership, as well as external partners (CROs, Laboratories, Specialty service-providers, Investigators).
• Work hand-in-hand with clinical trial associates and document control personnel to manage documents that are related to the clinical study.