Position summary:

• Recruit and screen participants, obtain informed consent, and ensure protocol
compliance.

• Collect and document data accurately, maintaining records per GCP standards.

• Liaise with investigators,...

Position summary:

• Responsible for document formatting, publishing, and regulatory submissions.

• Manage eCTD submissions, perform quality checks, and troubleshoot errors.

• Coordinate timely submission of regulatory dossiers (NDAs, BLAs).

Position summary:

• Oversee Patient Safety activities for assigned oncology compounds.

• Prepare and review safety documents (DSURs, PSURs, RMPs).

• Requires MD and expertise in FDA, EU, and ICH...

SUMMARY OF KEY RESPONSIBILITIES

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Lead the development strategy...

SUMMARY OF KEY RESPONSIBILITIES
• Provide strategic medical safety leadership and practical contributions for the Company’s assigned product(s) in a cross-functional setting.
• Perform safety signal management and...

NOTE: The title of the job depends on the discretion of the hiring manager.

Global Patient Safety

Responsibilities:

• With oversight from GPS TAH, responsible for...

ACDL is looking for a director safety sciences for one of its clients,

SUMMARY OF KEY RESPONSIBILITIES
• Manages all Company pre- and post-marketing safety surveillance activities for its...

We are using the same JD for multiple positions

NOTE: The title of this position depends on the discretion of the hiring manager.

SUSUMMARY OF KEY RESPONSIBILITIE

• Creates forms...

GENERAL POSITION SUMMARY
Director, Safety and Benefit-Risk Management will provide strategic and clinical leadership for all safety-related activities for investigational and/or marketed products, including the continuous assessment of their...

Overview

The Director, Clinical Operations will provide oversee the execution of clinical trials within the development programs. The incumbent will serve as the governance contact for the CRO and clinical...

SUMMARY:

We are currently looking for a skilled professional to join a well-known client’s team as Senior Clinical Study Manager. The responsibility will include to ensure on-time delivery of clinical...