GCP Compliance Manager - Clinical Programs & Trials

Posted 2 Days Ago
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2 Locations
In-Office
Senior level
Biotech • Pharmaceutical
The Role
The GCP Compliance Manager ensures adherence to Good Clinical Practice in clinical trials, providing guidance, oversight, and managing compliance-related activities across studies.
Summary Generated by Built In

Job Description Summary

#LI-Hybrid
For Hybrid working there is an expectation of 12 days per month onsite. This role can also be provided on a Remote working basis, subject to eligibility criteria. Eligibility for remote work can be discussed at interview stage.
Location: Westworks, London, UK
Other Locations: Dublin, Ireland. Please apply to the Dublin advertisement for this location
This role is based in London, UK. Novartis is unable to offer relocation support: please only apply if accessible. Novartis is unable to sponsor Visas for this location
Step into a role where your expertise helps Clinical Trial Teams navigate some of their most complex and high-risk decisions. As a GCP Compliance Manager – Clinical Programs & Trials, you will operate as a trusted partner embedded within the clinical trial environment, working across a portfolio of studies to provide expert guidance on Good Clinical Practice and support teams staying in compliance. You will support teams in solving complex scenarios which require careful risk-assessment —translating technical requirements into clear, actionable insights that enable informed decision-making.


 

Job Description

Acting as a key point of contact across study leaders, vendor managers, and cross-functional stakeholders, you will enable issue resolution, strengthen inspection readiness, and ensure trials are delivered to the highest standards of quality and compliance. This is a role for a curious, solutions-oriented professional who thrives on investigation, collaboration, and influencing outcomes in a fast-paced, global clinical landscape.

Key Responsibilities

- Provide compliance oversight for clinical programs and trials, ensuring adherence to Good Clinical Practice standards

- Act as primary compliance partner to Clinical Trial Teams, enabling decision-making on complex regulatory scenarios

- Lead cross-functional discussions and resolution of quality issues using structured investigation and root cause analysis

- Translate complex regulatory requirements into clear, actionable guidance for cross-functional clinical stakeholders

- Coordinate inspection readiness activities, including preparation and inspection management, in addition to subsequent CAPA management

- Monitor key indicators and trends to portfolio issues detect early signals, and support proactive mitigation strategies

- Deliver self-assessment checks and controls, sharing insights to strengthen compliance and continuous improvement

- Collaborate across functions, including Quality Assurance and Development, to ensure aligned and effective compliance practices

- Support quality assessments of programs and trials and enable informed, risk-based decision-making

- Champion a strong culture of quality, data integrity, and accountability across Global Clinical Operations and beyond

Essential Requirements

- Advanced degree in science, engineering, or related discipline

- Significant experience in clinical operations and clinical trial management within a pharmaceutical or healthcare environment

- Strong knowledge of Good Clinical Practice standards and global regulatory requirements

- Proven ability to investigate complex issues, perform root cause analysis, and develop effective corrective actions

- Excellent communication skills with ability to translate technical compliance concepts into clear, practical guidance

- Strong problem-solving mindset with curiosity and ability to navigate ambiguity and regulatory trade-offs

- Demonstrated ability to work effectively in cross-functional, matrixed teams and influence diverse stakeholders

- Ability to work independently, manage multiple trials simultaneously, and prioritise across competing demands

Desirable Requirements

- Experience supporting audits and inspections, including preparation and interaction with health authority inspections

- Openness to adopting and experimenting with artificial intelligence and new technologies to optimize ways of working


 

Skills Desired

Skills Required

  • Advanced degree in science, engineering, or related discipline
  • Significant experience in clinical operations and clinical trial management
  • Strong knowledge of Good Clinical Practice standards and global regulatory requirements
  • Proven ability to investigate complex issues
  • Excellent communication skills
  • Strong problem-solving mindset
  • Demonstrated ability to work effectively in cross-functional teams
  • Ability to work independently and manage multiple trials simultaneously

Novartis Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.

  • Healthcare Strength Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
  • Retirement Support Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
  • Parental & Family Support Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.

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The Company
HQ: Basel
110,000 Employees
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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