eTMF & Clinical Trials Operations Specialist (Hybrid)

Haleon plc.; New Jersey; Hybrid; USD 93,000 - 128,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Paid parental leave

Healthcare for you and family

Discretionary bonus

Job summary

Haleon plc. is seeking a Clinical Operations support professional to ensure efficient, timely, and compliant delivery of clinical trials. The role emphasizes eTMF management, documentation quality, and collaboration with study managers and the GSM SDP team in a hybrid NJ setting.

The position requires 5+ years in Clinical Operations, strong regulatory knowledge, and proficiency with Microsoft 365 tools. You will contribute to DSUR coordination and site communications as part of a global team.

Qualifications

• 5+ years of experience in Pharmaceutical Clinical Operations or Clinical Research support.
• Strong knowledge of the clinical research lifecycle and applicable regulations.
• Knowledge of ICH-GCP and study documentation standards.
• Experience coordinating across multiple workstreams and teams.
• Excellent written and verbal communication across functions.

Responsibilities

• Support TMF/EDL creation and filing per standards.
• Perform Periodic Review and QC of TMF artifacts.
• Produce regular eTMF status reports for management.
• Collaborate with GSM SDP team to raise issues and improve processes.
• Serve as Archival Champion for paper TMFs and assist with health authority requests.
• Create and maintain SharePoint sites for study teams.

Skills

Clinical Operations

Communication

Cross-functional collaboration

Organization

Attention to detail

Project coordination

Tools

Microsoft 365 tools

SharePoint

Job description

Haleon plc. is seeking a Clinical Operations support professional to ensure efficient, timely, and compliant delivery of clinical trials. The role emphasizes eTMF management, documentation quality, and collaboration with study managers and the GSM SDP team in a hybrid NJ setting.

The position requires 5+ years in Clinical Operations, strong regulatory knowledge, and proficiency with Microsoft 365 tools. You will contribute to DSUR coordination and site communications as part of a global team.