Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

An outstanding opportunity to craft the future of scientific advancements while ensuring flawless regulatory compliance. With a dedication to collaboration and innovation, you'll help us successfully implement regulatory strategies that drive our ambitious goals forward.
Key Responsibilities:
Document Management:

• Upload, track, file, maintain, and review all project-related documents according to relevant SOPs.
• Coordinate provision of initial country/site insurance documents per study and country requirements.
• Track and file the master ICF/additional master ICFs and related documents.
• Coordinate tracking and filing of country and site level ICF/additional ICFs and related documents.
• File training documentation in the Electronic Trial Master File (eTMF).
• Perform ongoing and final data reconciliation of all systems used during the study lifecycle.
• Revoke systems access for team members and site staff as necessary.

Financial Review and Management:

• Review finance documents and assess scope.
• Review current budget and assess amendment impact.
• Request clarifications and raise risks/issues to Project Lead and Financial Analyst.
• Contribute to Contract Modification (ConMod)/Change Notification Form (CNF) activities.
• Forecast and actualize units in Clarity monthly.

Project Planning and Implementation:

• Understand amendment scope, classification, and timelines.
• Confirm participant safety and plan amendment implementation strategy.
• Assess amendment impact for each functional area and vendors.
• Coordinate project and client training compliance.
• Ensure project team members complete training and document appropriately.

Regulatory and Submission Oversight:

• Provide oversight of planned and unplanned submissions to Regulatory Authorities and Ethics Committees (EC) for all regions.
• Coordinate submission strategy meetings and communicate submission plans and deadlines.
• Coordinate project-specific communication with Regulatory Authorities.
• Coordinate the development and translation of submission-related documents.
• Prepare the Core Dossier in the applicable Electronic Document Management System (EDMS).

Risk and Issue Management:

• Follow the Project Risk Management Process.
• Identify, advance, and resolve project issues through the Project Issue Resolution process (RESOLVE)
• Ensure audit/inspection readiness.

System and Data Management:

• Review and ensure accuracy of PPD systems in reporting trial achievements, progress, and risks.
• Raise outdated information requiring updates to the Project Lead.
• Perform final reconciliation of units in Clarity at study closeout.

Qualifications:

• Proven experience in project documentation management, regulatory submissions, and compliance.
• Strong understanding of financial documents and budget management.
• Proficient in using project management and documentation systems (e.g., Clarity, EDMS, eTMF).
• Excellent communication and organizational skills.
• Ability to manage multiple tasks and deadlines efficiently.
• Must be legally authorized to work in the United States without sponsorship
• Must be able to pass a comprehensive background check, which includes a drug screening.

Join us in making a difference in the world of science and innovation!

Skills Required