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 ResponsibilitiesTrial 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.
BenefitsHaleon 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 Date2026-11-03
