Clinical Trial Associate

Haleon; 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

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

The primary purpose of this role is to support Haleon Clinical Operations in the efficient, timely, and compliant delivery of clinical trials. The role will provide critical operational and administrative support, with a primary focus on electronic Trial Master File (eTMF) management and support for Clinical Operations Study Managers.

The position will help ensure clinical study activities and documentation are completed accurately and in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), internal policies, and applicable local regulatory requirements.

Key Responsibilities

Trial Master File (TMF) Support

• Provides process subject matter expertise and a quality approach for the creation of studies Expected Documents List (EDL) and placeholders’ creation, document filing and maintenance of TMF, and receipt of TMF transfer from third-parties closure of TMF in preparation for TMF lock, per Haleon’s written standards and system requirements.
• Initiate and provide support for Periodic Review process of eTMF as per internal processes, guidelines, and templates. Perform independent artefact Quality Control (QC) of documents as required per the TMF reference model requirements. Support study managers with documenting remediations where applicable.
• Generate regular eTMF status reports on completeness to support Study Managers and Regional Directors with management monitoring.
• Collaborate with eTMF Business System Administrator (GSM Systems Data and Processes (SDP) team) to raise issues encountered with eTMF, provide reference model review in anticipation of future updates, and provide input to processes and guidelines to improve working in eTMF. Support initiatives and represent Clinical Operations as a Subject Matter Expert (i.e., Champions Network)
• Act as local Archival Champions for paper TMFs and support with document retrieval to support Health Authority requests

General clinical study support

• Ad hoc member of the Clinical Study Team and provides expertise input to study team discussions at the Foundation Meeting, Clinical Study Team meetings, etc.
• Create and maintain SharePoint sites, supporting clinical operations team and specific study team sites.
• Act as DSUR Coordinators between sites and Haleon for studies where DSURs have been generated with unblinded data. Provide MyLesson support for studies, granting study sites access to Haleon’s learning module platform.

*This role is based in Berkley Heights, NJ, and follows a hybrid model, requiring an in-office presence of 3 days per week.

Why you?

Basic 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.
• Working knowledge of ICH-GCP requirements, particularly as they relate to clinical study documentation and records.
• Demonstrated experience coordinating, tracking, and managing clinical or operational activities across multiple workstreams.
• Strong written and verbal communication skills, with the ability to communicate clearly across functions and organizational levels.
• Proven ability to work effectively in cross-functional, collaborative team environments.
• Strong organizational skills and attention to detail, with demonstrated ability to manage multiple priorities and follow through on deliverables.
• Ability to operate with urgency, adaptability, and resilience in a fast-paced environment with changing priorities.

Preferred qualifications

• Advanced proficiency with Microsoft 365 tools, including Word, Excel, PowerPoint, SharePoint, email, and intranet-based platforms.
• Experience partnering cross-functionally with teams such as Medical Affairs, Finance, Clinical Operations, and external vendors.
• Excellent interpersonal skills with the ability to build effective working relationships across all levels of an organization.
• Demonstrated ability to develop practical solutions and tools that improve tracking, coordination, reporting, presentation, and communication.
• Ability to quickly learn and adopt new technologies and serve as a champion for new systems, platforms, and ways of working.
• Strong presentation and document-formatting skills, with the ability to produce clear, professional, and visually effective materials.

The salary range for this role is: $93,134 - 128,059 USD annually plus an annual bonus.

Benefits

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Job Posting End Date

2026-11-03

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.

During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees.

The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.