Senior Clinical Project Lead

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

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.