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Senior Clinical Study ManagerGSK • Weybridge, England, UK
Senior Clinical Study Manager

Senior Clinical Study Manager

GSK • Weybridge, England, UK
20 days ago
Job type
  • Full-time
Job description

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve 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 its 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.

Job Purpose

Are you energised by the opportunity to partner with key leaders in global medical science to enhance global operational support If so this Clinical Study Management Manager role could be an exciting opportunity to explore.

The role provides operational leadership to the Clinical Study Team and is responsible for the planning management execution and delivery of the trial according to study timelines budget and quality. The role will require robust use of project management tools and operational practices.

Key Responsibilities

  • Exhibits strong study operational strategy to plan and oversee execution of assigned studies supporting clinical strategy defined in the Non-Clinical & Clinical Development Plan.

  • Acts as Study Team Leader and primary operational contact for 13 trials of average design and protocol complexity including clinical trials behavioural testing and decentralised/virtual trials.

  • Has the ability and agility to manage the delivery of any type of study including complex or unusual study designs new indications challenging regional environments and local regulations while strategically influencing operational delivery.

  • Responsible for the implementation conduct and tracking of study trials in compliance with ICH/GCP and local regulations company SOPs and written standards for the conduct of human subject research study timelines budget and project specifications. Provides operational and strategic leadership to assure successful delivery of trials in alignment with Haleon expectations and behaviours.

  • Provides oversight of clinical sites CROs and vendor activities according to Functional Service Provider (FSP) or Full-Service Outsourcing (FSO) models. Leads or participates in clinical site assessments.

  • Leads the coordination of cross-functional department activities to successfully achieve milestones and quality deliverables in study management including study start-up recruitment study conduct database lock and study close-out with risk and issue management and assurance of TMF inspection readiness.

  • Contributes to plans and study documents from an operational standpoint such as protocols informed consent forms monitoring plans vendor contracts and clinical study reports.

  • Acts as HBS custodian.

  • Takes on functional leadership responsibilities providing expert consultation for issue resolution and piloting new ways of working.

  • Represents Clinical Operations in vendor and due diligence/audit activities and provides subject matter expertise on implementing Good Clinical Practice business improvement initiatives and change implementation.

Key Competencies

Skills & Experience

  • Bachelors degree.

  • 5 or more years of industry project management experience.

  • Relevant clinical research or operational specialty training preferred.

  • Experience providing operational support across global scientific and medical functions.

  • Externally facing role experience and technical expertise.

Desirable

  • Advanced degree in Life Sciences.

  • Strong stakeholder management experience.

  • Proven ability to influence and build consensus.

Job Posting End Date

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. Its 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.

Adjustment or Accommodations Request

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process please let your recruiter know by providing them with a description of specific adjustments you are requesting. Well provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.


Required Experience:

Manager


Employment Type : Full-Time
Experience: years
Vacancy: 1
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Senior Clinical Study Manager • Weybridge, England, UK

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