Contracting Specialist Clinical Study Start-Up
Job Summary
Salary Range:
32690.00 - 60710.00Band
Level 3Job Description Summary
#LI-HybridLocation: 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 were committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: 32690.00 - 60710.00 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 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:
Commitment to Diversity and Inclusion / EEO
Novartis is committed to building an outstanding inclusive work environment and diverseteamsrepresentative of the patients and communities we serve.
Skills Desired
Budgeting Clinical Research Clinical Studies Clinical Trials Conflict Management Contract Agreements Contract Management Contract Negotiations Financial Analysis Good Clinical Practice (GCP) Negotiation Study Start Up Vendor Management Vendor Partnerships Vendor ProcurementRequired Experience:
IC
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.