Clinical Trials eTMF Specialist

Haleon; New Jersey; On-site; USD 93,000 - 128,000; Full time

Benefits offered by this job

401(k) plan

Healthcare benefits

Discretionary bonus

Tuition reimbursement

6 months paid parental leave

Job summary

Haleon is seeking a Clinical Operations professional to support efficient, compliant delivery of clinical trials. You will focus on eTMF management, including EDList creation, TMF maintenance, and collaboration with the GSM SDP team to resolve issues and improve processes.

The role requires 5+ years in clinical operations, strong documentation discipline, and proficiency with Microsoft 365 tools. A Bachelor’s degree in life sciences is preferred.

Qualifications

• 5+ years in Pharmaceutical Clinical Operations, Medical Operations, or Clinical Research support.
• Knowledge of clinical research lifecycle and regulatory requirements.
• Experience coordinating activities across multiple workstreams.
• Familiarity with GCP, ICH guidelines, and study documentation.
• Strong written and verbal communication across functions and levels.

Responsibilities

• Provide TMF support, create EDLs, file and maintain TMF.
• Initiate periodic review of eTMF per guidelines and templates.
• Perform QC of documents per TMF requirements.
• Support study managers with remediations where applicable.
• Generate regular eTMF status reports for management.
• Collaborate with GSM SDP team to address eTMF issues and improve processes.

Skills

Clinical operations experience

Cross-functional coordination

Documentation & QC

Written & verbal communication

Organization & multitasking

Education

Bachelor's degree in Life Sciences/Pharma

Tools

Microsoft 365

SharePoint

Excel

PowerPoint

Job description

Haleon is seeking a Clinical Operations professional to support efficient, compliant delivery of clinical trials. You will focus on eTMF management, including EDList creation, TMF maintenance, and collaboration with the GSM SDP team to resolve issues and improve processes.

The role requires 5+ years in clinical operations, strong documentation discipline, and proficiency with Microsoft 365 tools. A Bachelor’s degree in life sciences is preferred.