Senior Clinical Trial Manager
Arena Pharmaceuticals
Zug, Switzerland
vor 5 Tg.

The Opportunity : Senior Clinical Trial Manager

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

The Senior Clinical Trial Manager (Sr. CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH / GCP and SOPs.

  • The Sr. CTM leads the cross-functional clinical trial team and partners with internal and external team members / key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to : CRO and vendor selection, contracting and management;
  • inspecting and monitoring CROs; clinical trial protocols and patient recruitment; system design and activation; risk mitigation plans and assessments;
  • reporting and metrics; and safety events and reporting.

    What you’ll dive into :

  • Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial team in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines
  • Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting
  • Proactively identifies and resolves operational issues / processes to ensure achievement of study milestones, data quality and data integrity;
  • escalates study-related issues appropriately in a timely manner

  • Obtain and relay key study issues, status updates and other study information to the clinical trial team and management
  • Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
  • Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.
  • g., central laboratory, CROs), as needed, to support clinical trial activities

  • Provides input on the development of eCRF design
  • Participates in IRT, EDC and ePRO user acceptance testing
  • Participates in data cleaning, listing, and report output reviews
  • Develops, reviews, and approves study-related manuals, plans, specifications, charters, newsletters, and materials
  • Participates in protocol deviation listing reviews and meetings
  • Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments
  • Participates in protocol, table, figure, data listings and clinical study report reviews
  • Provides input / reviews DSUR, PSUR and regulatory annual and periodical reports
  • Develops presentations for clinical sites, team and investigator meetings
  • Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready
  • May be responsible for a defined region, vendor or process across a program
  • May have functional reporting responsibilities
  • Performs other work-related duties as assigned or required
  • Demonstrates interpersonal versatility, able to simultaneously serve as an individual contributor and a leader
  • Thinks strategically and tactically
  • Ability to manage trial(s) independently with minimal oversight
  • Leads through influence with ability to manage and mentor internal personnel and external resources
  • Participates in the identification and selection process for CROs and vendors
  • Provides input on protocol design and statistical analysis plan (SAP)
  • Mentors less experienced Clinical Trial Managers and Clinical Operations team members; assists with team development
  • Qualifications :

  • Bachelor’s degree
  • 8+ years of relevant and progressive clinical trial management experience
  • Experience in full-cycle drug development
  • Strong understanding of clinical trials processes, protocols and medical terminology
  • Strong experience utilizing CTMS, EDC, TMS and related software
  • Prior experience in management and monitoring of CRO and investigative sites
  • Strong experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management
  • Broad knowledge of ICH, GCP, IRB / IEC and local regulatory authority drug research & development regulations
  • Advanced experience with bio-samples, storage of 3rd party data
  • Motivated to work in a fast-paced, high accountability environment
  • Experience in Arena’s focused therapeutic areas, preferred
  • Travel up to 25%
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