Remote Senior Manager, Integrated CTD/PV Data Process

USDM Life Sciences; United States; Remote; USD 96,000 - 110,000; Full time

Job summary

USDM Life Sciences is seeking a Sr. Manager, Integrated Clinical Trial Data Process to lead process development for CTD and Pharmacovigilance initiatives. The role emphasizes creating process maps, RACIs, procedures, and job aids, in partnership with accountable Takeda stakeholders who own governance and final approvals.

The candidate will facilitate cross-functional workshops, document requirements, and maintain project plans and risk logs in a global, remote setting.

Qualifications

• Operational experience in Clinical Operations, Study Management, Data Management, and/or Pharmacovigilance.
• Working knowledge of GxP quality systems and ICH GCP.
• Experience translating complex operational requirements into process maps and related content.

Responsibilities

• Partner with stakeholders to execute process-development for CTD and PV initiatives.
• Create and update Lucid process maps using approved requirements and stakeholder input.
• Facilitate cross-functional workshops and SME interviews to gather requirements and clarify roles.
• Draft and revise process documentation per quality and document-control requirements.
• Coordinate PleaseReview workflows and maintain review records.
• Maintain project plans, RAID logs, and deliverable trackers for initiatives.
• Identify risks, dependencies, decisions, and next steps for initiatives.
• Provide recommendations within scope and escalate as needed.

Skills

Clinical Operations

Study Management

Data Management

Pharmacovigilance

GxP quality systems

ICH GCP

Cross-functional facilitation

Process mapping

Education

Bachelor’s degree

International equivalent

Tools

Lucid

Document-review workflows

Job description

USDM Life Sciences is seeking a Sr. Manager, Integrated Clinical Trial Data Process to lead process development for CTD and Pharmacovigilance initiatives. The role emphasizes creating process maps, RACIs, procedures, and job aids, in partnership with accountable Takeda stakeholders who own governance and final approvals.

The candidate will facilitate cross-functional workshops, document requirements, and maintain project plans and risk logs in a global, remote setting.