Senior Global Clinical Trial Manager (m/f/d)

Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort

 

To support their expanding Clinical Operations Team we are looking for a:

Senior Global Clinical Trial Manager (m/f/d)

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    München

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    26548

  • Aktualisierung:

    06.04.2021

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Your tasks

  • Lead cross-functional teams and supervise vendors to ensure clinical trials are executed
  • Provide operational expertise to meet scientific objectives of the clinical studies
  • Partner closely with clinical development functions to design and write clinical trial protocols
  • Independently draft, review and implement study management plans and vendor oversight plans; ensure CROs and other vendors adhere to study plans
  • Provide direction and oversight of CROs and vendors to ensure delivery against scope of work; manage vendors by key performance indicators
  • Lead the identification and selection of study CROs and vendors, including negotiation of scope of work and budgets
  • Conduct study feasibility assessments; partnering with team and program lead on final country and site selection
  • Plan and execute investigator meetings and train vendors/ internal staff on study protocol and processes
  • Work with external partners to ensure that clinical data from a variety of sources is appropriately captured and of high quality
  • Participate in the ongoing and final review of study data and assessment of the impact of the data to the clinical development program
  • Proactively identify and mitigate study-specific risks; effectively communicate study status, risks, and changes that may impact quality, timelines, and cost to internal and external stakeholders
  • Manage study budget; identify and communicate variances
  • Participate in and lead department process improvement initiatives and system implementation
  • Review and provide input on cross functional SOPs, working practices and assist in the creation and improvement of department infrastructure as directed
  • Support preparation for Regulatory inspections

Your qualifications

  • Advanced scientific degree (MS/MSc/PhD) in life sciences or related discipline is prefered however can be replaced by a strong, proven experience in comparable positions or responsibilities
  • 5+ years of experience in clinical development in the biotech, pharma or CRO industry
  • Experience in immunology or related therapeutic area
  • Proven ability to successfully plan, implement, and manage global clinical trials
  • Ability to manage cross functional clinical study teams to high performance
  • Proven ability to effectively manage and negotiate with CROs and clinical study vendors
  • Strategic thinking and project management skills
  • Agility and flexibility
  • Strong working knowledge of FDA, EMA & ICH/GCP regulations and guidelines
  • Highly effective verbal and written communication and presentation skills in English
  • Ability to travel

Ihr Ansprechpartner

Tilman Grumbd
Geschäftsführer

Anschrift

Optares Medical GmbH & Co. KG
Tilman Grumbd
Heiligengeist Höfe 8
26121 Oldenburg