Hybrid eTMF & Clinical Operations Specialist

Haleon; Warren Township (NJ); Hybrid; USD 93,000 - 128,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Paid parental leave (6 months)

Healthcare coverage

Job summary

Haleon is seeking a Clinical Operations professional to support efficient and compliant delivery of clinical trials, focusing on electronic Trial Master File management and study-manager support. The role is based in Berkley Heights, NJ, on a hybrid model requiring in-office presence three days a week.

You will collaborate with the eTMF GSM SDP team, ensure quality control, and assist with archival duties while coordinating with cross-functional teams to maintain regulatory compliance and study

Qualifications

• 5+ years of experience in Pharmaceutical Clinical Operations, Medical Operations, or Clinical Research support.
• Working knowledge of the clinical research lifecycle, processes, and applicable regulations.
• Knowledge of ICH-GCP requirements related to study documentation and records.
• Ability to coordinate, track, and manage activities across multiple workstreams.
• Strong written and verbal communication skills across functions and levels.

Responsibilities

• Provide TMF support including creation of EDL, placeholders, filing, and TMF transfer from third parties.
• Perform Periodic Review and QC of TMF artifacts; assist with remediations.
• Generate regular eTMF status reports for Study Managers and Regional Directors.
• Partner with GSM SDP team to address eTMF issues and contribute to process improvements.
• Act as local Archival Champion for paper TMFs and assist with document retrieval for Health Authority requests.

Skills

Clinical Operations

ICH-GCP

Cross-functional coordination

Communication

Organizational skills

Microsoft 365

Tools

Microsoft Word

Excel

PowerPoint

SharePoint

Job description

Haleon is seeking a Clinical Operations professional to support efficient and compliant delivery of clinical trials, focusing on electronic Trial Master File management and study-manager support. The role is based in Berkley Heights, NJ, on a hybrid model requiring in-office presence three days a week.

You will collaborate with the eTMF GSM SDP team, ensure quality control, and assist with archival duties while coordinating with cross-functional teams to maintain regulatory compliance and study