Contracting Specialist - Clinical Study Start-Up

Novartis

Greater London

Hybrid

GBP 33,000 - 61,000

Full time

3 days ago

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Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

14 weeks paid parental leave

Company vehicle or car allowance

Job summary

Novartis in London seeks a Contracting Specialist - Clinical Study Start-Up to lead contracting activities that enable clinical studies to launch. You will collaborate with internal and external stakeholders to negotiate contracts and manage study agreements, accelerating site activation and patient recruitment.

The role requires experience in SSU or related research, with a focus on regulatory compliance, negotiations and cross-functional coordination in a hybrid work setting.

Qualifications

Minimum one year in a clinical trials or SSU environment.
Experience supporting clinical research or site-facing trial activities.
Understanding of ICH-GCP, IRB/IEC, and HA regulations.
Strong communication and stakeholder relationship skills.
Proven negotiation skills for financial and contractual discussions.
Ability to manage multiple priorities and meet timelines.
Experience with databases and multiple information sources for data analysis.
Accountability and adaptability in a regulated environment.

Responsibilities

Support country SSU strategy to deliver country timelines and milestones.
Coordinate and execute clinical study contracts and confidentiality agreements.
Track contract status from negotiation to return and manage risks.
Negotiate financial and legal terms with sites and budgets.
Collaborate with CRAs, CTAs, Finance, SSU Managers, and global study teams to progress start-up activities.
Serve as contact for local legal teams and ERCs on contract matters.
Ensure contracting complies with ICH-GCP, IRB/IEC, HA regulations, and SOPs.
Drive streamlined contracting processes to accelerate site activation and recruitment.

Skills

Communication

Negotiation

Stakeholder management

Regulatory understanding

Risk management

Data analysis

Multi-tasking

Job description

Salary Range: £32,690.00 - £60,710.00

Job Description Summary

#LI-Hybrid

Location: London, UK

Relocation Support: This role is based in London, UK. Novartis is unable to offer relocation support: please only apply if accessible.

Novartis operates a Hybrid working policy with an expectation of 12 days per month onsite.

Clinical trials rely on strong partnerships, effective negotiations and seamless coordination to move from planning to patient enrolment. As a Contracting Specialist - Clinical Study Start-Up, you will play a vital role in accelerating the delivery of innovative medicines by leading the contracting activities that enable clinical studies to launch successfully.

Working at the centre of Study Start-Up activities, you will collaborate with a broad network of internal and external stakeholders to negotiate contracts, manage critical study agreements and help ensure sites can begin enrolling patients as quickly as possible. Your work will have a direct impact on study activation timelines, patient recruitment opportunities and the successful delivery of clinical research.

Job Description

Key Responsibilities

Support country Study Start-Up (SSU) strategy, partnering with SSU Managers and Team Leads to deliver country-level timelines, milestones and study start-up commitments.
Coordinate, prepare and execute clinical study contracts, confidentiality agreements and contract amendments across assigned studies, sites and institutions.
Track and oversee contract status from negotiation through dispatch, execution and return, proactively managing risks and escalating issues where required.
Negotiate financial and legal terms with sites and institutions, reviewing study documentation, budgets and tariffs to support timely study activation.
Collaborate closely with Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs), Finance Specialists, SSU Managers, global study teams and external research partners to ensure parallel study start-up activities progress efficiently.
Serve as the primary point of contact for local Legal teams and Ethics Review Committees (ERCs), supporting contract-related matters including patient reimbursement topics.
Ensure all contracting activities comply with financial standards, prevailing legislation, International Council for Harmonisation Good Clinical Practice (ICH/GCP), Institutional Review Board and Independent Ethics Committee (IRB/IEC) requirements, Health Authority (HA) regulations and Novartis Standard Operating Procedures (SOPs).
Drive innovative and efficient contracting processes that streamline study start-up, accelerate site activation and support patient recruitment objectives.

Essential Requirements

Minimum one year of experience within a clinical trials, clinical operations, Study Start-Up (SSU) or related research environment.
Previous experience supporting clinical research, study start-up or other site-facing clinical trial activities.
Understanding of clinical trial processes, documentation and regulatory requirements, including International Council for Harmonisation Good Clinical Practice (ICH/GCP), Institutional Review Board and Independent Ethics Committee (IRB/IEC) requirements and Health Authority (HA) regulations.
Strong communication and stakeholder management skills, with the ability to build effective relationships across diverse internal and external partners.
Demonstrated negotiation skills and the confidence to participate in financial, contractual and operational discussions.
Ability to manage multiple priorities simultaneously and deliver high-quality outcomes within agreed timelines.
Experience working with databases, systems and multiple information sources to analyse data, compare information and develop recommendations.
Strong sense of accountability, ownership and personal responsibility for delivering commitments in a regulated environment, supported by an agile learning mindset and the ability to quickly learn new processes, systems and ways of working.

Desirable Requirements

AI and Digital Readiness, including openness to learning and using AI tools, willingness to experiment with new technologies, ability to critically assess AI-generated outputs, and adaptability to increasing AI enablement within future workflows. AI experience is considered desirable but not mandatory.
Experience gained within a Contract Research Organization (CRO), National Health Service (NHS), academic research institution or life sciences environment.

Benefits & Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 32,690.00 - 60,710.00 GBP Annual

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

You may be eligible for a company vehicle or a car allowance in accordance with the applicable local Novartis policies and guidelines.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:

https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired