Senior Manager Clinical Operations

On behalf of our partner a renowned, globally acting Swiss biopharmaceutical company based in the Basel region dedicated to the research, development, and commercialization of innovative medicines we are looking for a motivated and qualified Senior Clinical Trial Manager.

As the exclusive recruitment partner for this vacancy, we are managing the entire selection process. For you, this ensures personalized, discreet guidance, transparent communication, and efficient decision-making paths throughout your application journey.

• Trial Execution & Leadership
  :
  Lead the operational planning, set-up, conduct and closeout of clinical trials, with a primary focus on a high-priority Phase III study
• Project & Budget Managemen
  t:
  Accountable for timely, high-quality trial delivery. Prepare trial budgets, financial forecasts, timelines, and comprehensive project plans
• Vendor & CRO Surveillanc
  e:
  Manage requests for proposal (RFPs), negotiate vendor contracts, and maintain close oversight of CROs and other third-party providers (central labs, IWRS, clinical supply distributors)
• Clinical Documentatio
  n:
  Provide key input for clinical study protocols, Investigator’s Brochures (IB), and Informed Consent Forms (ICF). Prepare and review trial manuals, guidelines, visit reports, and newsletters
• System Implementatio
  n:
  Perform User Acceptance Testing (UAT) for clinical systems implemented within the trial
• Stakeholder Communicatio
  n:
  Plan, lead, or participate in project meetings, training workshops, and investigator meetings. Prepare regular status reports, summaries, and ad-hoc analyses
• Quality & Complianc
  e:
  Conduct co-monitoring and oversight visits, participate in internal/external audits, and ensure the TMF/eTMF is accurately set up, regularly updated, and inspection-ready at all times

• Experienc
  e:
  At least 5-10 years of experien
  ce managing clinical trials (Phases I–III), showcasing a career progression from a CRA level up to a Global Clinical Trial Manager.
• Monitoring Backgroun
  d: A minimum of 1 year of hands-on CRA experien
  ce is highly preferr
• edPast Sponsor Exposure
  :
  Is a requirement for this role
• Technical Proficienc
  y:
  Solid, practical understanding of clinical trial systems, including EDC, IRT, eTMF and CT
  MS
• Regulatory Knowledg
  e:
  Robust and up-to-date knowledge of ICH-GCP guidelin
  es and clinical trial regulations across multiple countries
• Audits & Inspection
  s:
  Previous involvement in internal audits or regulatory authority inspections is considered a strong asset
• Soft Skill
  s:
  Strong organizational, problem-solving, and time-management skills, combined with effective, professional communication