Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company, headquartered in the heart of the life sciences hub of Basel, Switzerland.
We are an innovative and multinational team of 225 employees worldwide and committed to discovering, developing and bringing to market medicines that make a clear difference to the lives of patients. Our activities are focused on the therapeutic areas of oncology and anti-infectives, with two commercialized drugs in our portfolio (Cresemba® and Zevtera®).
 
 
For our Development Department we are currently looking for an experienced
 

Clinical Operations Manager (M/F) 

Your tasks

  • Plan, set-up and conduct of clinical trials phase 1 to 3
  • Prepare trial budgets, forecasts, recruitment projections and project plans
  • Negotiate contracts and budgets for assigned clinical trials in cooperation with Finance Department and Project management
  • Management and surveillance of CRO(s) and third party vendors
  • Plan and manage Investigator Meetings, Kick-off and other study related internal and external meetings
  • Contribute to effective set-up and maintenance of relevant systems such as EDC, IRT, eTMF, etc.
  • Develop and monitor Key Performance Indicators, Risk Registers and mitigation measures
  • Provide input to clinical study protocols, IB, patient information sheets, etc.
  • Reviews and/or prepares study specific manuals, guidelines, questionnaires, and participates in the periodic review and revision of departmental SOPs and policies
  • Conducts oversight visits at investigational sites
 

Your profile

  • Minimum 3 years experience in managing clinical trials phase II – III, preferably in roles of growing responsibilities
  • Experience as CRA considered highly beneficial
  • Experience working hands-on on phase I, II and III studies in cross-functional environment at a CRO or study sponsor
  • Strong understanding of various functions’ contributions in the set-up and conduct of clinical trials
  • Solid understanding of common clinical trial systems (EDC, IRT, eTMF, CTMS, etc.)
  • Sound knowledge of ICH-GCP and clinical trial regulations across regions and countries
  • Excellent communication skills across all levels, internally, externally, cross-functionally and in a highly collaborative matrix environment
  • Excellent team and problem solving skills in international and cross-functional environment
  • Fluent in English, knowledge of German and additional languages is a plus


Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on interesting, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success.

If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application via our careers portal.

Additional information can be found on our website www.basilea.com.