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Clinical Operations Lead

2 months ago

UK, UK, United Kingdom i-Pharm Consulting Full time

Job Title: Manager, Strategic R&D Business Operations
Location: London

Company Description:
Our Client is a global leader in delivering innovative therapeutics for patients with serious and life-threatening rare genetic diseases. Our focus is on advancing therapies that are first or best of their kind, offering hope where few or no treatment options exist. Many of the conditions we target are inherited, progressively debilitating, and affect relatively small patient populations, including children.

About the Opportunity:
The Manager, Strategic Research and Development Business Operations, is a pivotal role within our Business Operations team, serving as the Business Programs Site Manager (BPSM) for assigned programs. Reporting to the Site Contracts Functional Lead, the BPSM manages the lifecycle of clinical trial site contracts and budgets from development through close-out. You will also contribute to the broader clinical portfolio business operations, including vendor contract management and financial oversight of clinical trials.

Key Responsibilities:

  • Financial Management: Oversee site-budget related financial activities, ensuring alignment with the global site budget and contracting strategy.
  • Clinical Trial Strategy: Collaborate with Global Study Operations to align on trial execution strategies.
  • Site Budget & CTA Management: Act as the primary point of contact for site budgets and Clinical Trial Agreements (CTAs), resolving budget, contract, or payment issues.
  • Assumption & Metrics Development: Develop clinical trial assumptions, drive program milestones, and monitor metrics.
  • Site Selection Input: Provide insights into site selection and feasibility based on contracting timelines and budget considerations.
  • Budget Development: Create study/country/site budget templates, conduct budget analysis, and negotiate budget line-items using available benchmarking tools.
  • Contract Negotiation: Manage site agreements, conduct contract negotiations, and ensure all contract documentation is accurately tracked and filed.
  • Site Amendments & Payments: Process amendments as needed and facilitate reconciliation of site payments.
  • Vendor Oversight: Support vendor/CRO performance oversight for outsourced work.
  • Risk Management: Advise internal stakeholders on budget-related risks and propose mitigation strategies.

Must Have:

Education:

  • BA/BS in finance, accounting, health sciences, or related degree. Advanced degree preferred. Experience in lieu of education is considered.

Experience & Key Competencies:

  • 8+ years of relevant experience in the pharmaceutical industry (including CROs).
  • 5+ years of experience in Clinical Operations or Business Operations, including site and/or vendor contracts and budgets.
  • Strong knowledge of U.S. and global site contracting and budgeting processes.
  • Proven ability to manage site contracting processes with minimal oversight.
  • Excellent planning, communication, and problem-solving skills.
  • Experience collaborating across functional teams to drive solutions.
  • Commitment to business ethics and resilience in challenging environments.

Nice to Have:

  • Understanding of clinical site payments processes and region-specific nuances.
  • Familiarity with clinical trial protocols and their impact on site contracts and budgets.