Our client, an international research-based pharmaceutical company in Nordrhein-Westfalen is looking for an
International Operations Lead (m/f)
The company operates in the areas of pain treatment, women’s health, inflammation, neurology, perioperative care, cancer supportive care, serves customers internationally and is present in 32 countries with affiliates in Europe, Australia, Latin America and the US.
Purpose of the role
The IOL is the operational lead for the clinical project team and is responsible for the operational strategy and contributes to the scientific strategy to ensure delivery of the global clinical project in accordance with the appropriate quality standards. The IOL covers one or several programs (on a product/substance level) globally.
Duties and responsibilities:
Provides operational and strategic direction to the clinical project team of one or more clinical study teams (matrix structure, no direct line management)
Provides strategic direction and leadership to one of more Global Operations Study Leaders (GOSLs) in ensuring delivers of all cross functional activities
Oversees the progress of the clinical project against the objectives, with regard to timelines, resources and budget, direct cost and FTEs
Provides direction and oversight of outsourced activities
Collaborates with and supports current and prospective clinical project plans
Responsible for the clinical project budget, consisting of both clinical trial and non-clinical trial costs
Responsible for the operational review of and preparation of cost estimates, project plans and do-ability assessments for new projects
Member of the Clinical Core Team
Strong leadership and motivational skills developed through leading successful global multi-functional matrix study teams through all stages of clinical studies
Demonstrated consistent achievement of team delivery against commitments and goals
Experienced project manager, having led the development and implementation of risk management plans, managed complex study budgets and resourcing plans
Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team and coordinating study level activities to deliver data for filing or publication purposes
Several years’ experience in Clinical Development or Clinical Operations in total
Why this vacancy is right for you:
Our client offers an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.