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Manager Study Start Up

12 minutes ago
United States
Full-time
Senior
Program Manager
Project and Program Management
GCP
Apply Now
Summit Therapeutics

Summit Therapeutics

Summit Therapeutics is a clinical stage drug discovery and development company dedicated to advancing innovative therapies to address serious unmet medical needs. With a focus on oncology, Summit is committed to improving the quality of life and increa...

Pharmaceuticals
51-250
Founded 2003
View All Jobs 4

Description

  • Manage day-to-day Study Start Up operations to support completion of program goals in compliance with GCP/ICH and other regulatory requirements.
  • Negotiate and finalize site agreements, budgets, contracts, and related documentation.
  • Provide accurate project status and financial updates in tracking systems and tools.
  • Present budget details for approval to senior leadership.
  • Partner with Clinical and Finance teams to develop site payment estimates and forecasts.
  • Work with legal counsel to ensure indemnification, liability, and confidentiality terms are included in agreements.
  • Provide regular progress updates and KPI reporting on trial agreements and site activation.
  • Resolve budget, invoice, payment, purchase order, and site agreement issues with internal stakeholders.
  • Build relationships with study teams, CROs, FSP providers, and clinical sites to support activation strategies.
  • Develop pricing strategies, improve SSU processes and tools, and oversee team deliverables.

Requirements

  • Degree in Life Sciences, Business Administration, or a related field preferred; equivalent clinical and industry experience considered.
  • 5-7 years of experience for Manager level, or 10+ years for Sr. Manager, in feasibility, study start-up, clinical trial site agreements, and eTMF within biotech or pharma.
  • Knowledge of clinical trial conduct, including multi-center global trials.
  • Strong knowledge of ICH/GCP guidelines and regulatory requirements.
  • Excellent interpersonal, written, verbal, administrative, and computer skills.
  • Experience working cross-functionally and with external providers.
  • Experience with process improvement initiatives.
  • Proficiency with MS Office, electronic document management systems, and document review tools preferred.
  • Strong computer and database skills, plus the ability to multi-task and manage confidential, time-sensitive documents.
  • Direct negotiation experience with sites and vendors required.
  • Strong knowledge of grant plan or similar benchmarking tools.
  • Good understanding of the clinical operations process.
  • Global site activation experience, including submission requirements, preferred.
  • Experience executing feasibility and study start-up for Global Phase 2 and Phase 3 trials preferred.
  • Strong global negotiation and contract management skills preferred.
  • Strong financial acumen and experience creating and managing site budgets preferred.
  • Experience with large, multi-site clinical trials and multiple vendor types preferred.

Benefits

  • Base salary range of $139,000 to $163,000 USD.
  • Total compensation may include bonus, stock, benefits, and other variable compensation.
  • Compensation may be adjusted based on experience, certifications, and work location.
  • Equal Opportunity Employer with a diverse, non-discriminatory workplace.

Interested in this position?

Apply directly on the company website

Apply Now

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