Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

Sr. Business Analyst – eTMF

The primary purpose of this role is to support the Consumer Health Clinical Development team through support of the Electronic Trial Master File (eTMF) system used by Clinical Operations, Safety, Medical Affairs and other functions to ensure optimal use of TMF functionality and TMFs are maintained in an inspection readiness state.

The role will involve interaction with business users and Tech partners to assess current state, continuously evaluating regulatory requirements for TMF management (active and archival). In addition, this role will assess the impact to the company’s established processes, and intervene as issues are identified in order to support the business in identifying operational efficiencies and KPI reporting on business activities.

Key Responsibilities:

• Manage eTMF system and administration support to business users within the CH R&D organization including Clinical Development, Medical Affairs, Regulatory, Quality and other business functions.
• Work in close collaboration with clinical business system owner colleagues to provide coverage across applications and assess impact of enhancements across eTMF and the clinical systems suite.
• Accountable for resolving and escalating incidents, managing user requests in collaboration with Consumer Healthcare (CH) Tech team
• Participate in discussions with business stakeholders to understand business requirements, document user requirements and participate in prioritizing the eTMF Backlog List, in collaboration with CH Tech partner.
• Participate in close collaboration with CH Tech during sprint and release planning, incident reviews and test execution.
• Support Data Quality standards are considered and maintained through all system versions.
• Develop important messages relevant to all levels of stakeholders, including content and plan of systems releases, issues, etc
• Manage the preparation, maintenance and execution of test scripts as required. Work in close collaboration with Tech on testing and implementation of changes, identify candidates for automated testing, support and verify test environment preparation and confirm that acceptance criteria have been met. Ensure GCP requirements and inspection readiness are maintained and current.
• Support Audit/Assessment/Inspection readiness and participate in system internal audits and/or external inspections as needed.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Science or Information Technology
• 3 + years’ experience in the pharmaceutical industry and/or consumer goods industry
• Experience and demonstrated cross-functional understanding of the clinical research process specifically the stages of a clinical trial and the corresponding records required and regulations, ICH GCP and GxP regarding systems documentation
• Experience and understanding with the DIA TMF Reference Model
• Experience with Veeva Vault or equivalent system
• Experience with supporting clinical systems
• Experience working within Agile delivery methodology with an understanding of the system development life cycle a plus

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced Degree preferred
• Technical background and computer proficiency in a variety of clinical trial systems, and report-building capabilities
• Track record of success in continuous improvement, innovative work practices and driving change
• Excellent interpersonal and written and verbal communications skills with a proven ability to interact well with all levels
• Ability to identify opportunities for process and compliance improvements
• Enhanced customer service orientation and ability to communicate professionally to diverse cross functional non-technical and technical audiences
• Experience in work requiring high level of attention to detail and excellent follow-up
• Ability to learn new technologies quickly & be knowledgeable about integration of new platforms as required
• Self-motivated, able to resolve issues with cross-functional teams with minimal supervision

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

• LI-Haleon

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