Senior International Project Leader (m/w/d)

Phase IIIb / Phase IV / Non Interventional Studies

Our Client is a worldwide leading pharmaceutical company originated in Japan with a more than 100 years lasting and prosperous R&D-tradition with therapeutical focus on business units Cardiovascular, Diabetes, Immunology and Oncology.

 

We are searching as soon as possible for a

Senior International Project Leader (m/w/d)

Phase IIIb / Phase IV / Non Interventional Studies

  • Bereich:

    Medical

  • Berufssparte:

    Projektmanagement/Projektleitung

  • Arbeitsregion:

    Greater Munich Area

  • Art der Anstellung:

    permanent

  • Kennziffer:

    26282

  • Aktualisierung:

    2020-11-04

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Your tasks

  • Responsible for the conception, planning, conduct and evaluation of interventional (phase IIIb, IV trials) and non-interventional studies (eg. classical non interventional studies, , Post Authorization studies, Epidemiological Trials
  • Take ownership of a clinical projects from the beginning till closure, provide leadership and deliver studies on time and on budget with high quality
  • Take the lead in a matrix by managing remotely and by understanding the European needs. Take leadership for all divisions involved (eg, contract research organization, Medical Affairs, PRA/HEOR, Pharmacovigilance, Biostatistics) 
  • Interface with Affiliates by understanding the needs and by involving the Medical Liasons in the trial
  • Make decisions related to process efficiencies and budget
  • Development of risk mitigation strategies for key operational tasks
  • Generation, review and approval of trial related documents (eg. protocol, CSFs, reports, project plans), supervision of the preparation of study related documents for submissions to ECs/CA and other regulatory bodies 
  • Generation and review of trial and disease related medical material and communication (incl. publications) 
  • Daily management and supervision of CROs and other 3rd party service providers; active participation in the related outsourcing and procurement processes 
  • Best practice sharing and study management standards implementation 
  • Study and disease area related interactions with KOLs and HCPs in Steering Committees, Advisory Boards, Data Safety Boards and Investigator Meetings 
  • Participation in development program related internal and external trainings and seminars 
  • Tight collaboration with Medical Affairs assuring study designs are in accordance with the global medical strategy as well as with HEOR/PRA ensuring optimal reflection of pricing and reimbursement needs in all relevant studies
  • Participation in global committees
  • Oversee progress of Investigator Initiated studies 

Your qualifications

  • MD or natural science education and degree, doctorate preferred  
  • Minimum of 5 years relevant experience in international clinical research and international project management in a multi-national pharmaceutical industry and/or CRO environment
  • Thorough knowledge of the management of EU wide non-interventional trials including regulatory local requirements, guidelines, and other relevant health system/legal requirements specifically related to late-phase clinical research
  • Strong knowledge of Clinical Research Principles (ICH –GCP) 
  • Leadership experience with active participation in multicenter trials 
  • Documented track record in multidisciplinary, cross-functional interactive collaboration with Medical Affairs, HEOR/PRA and other relevant key functions; familiar to work in an international matrix organization
  • Fluency in English and at least one other European language, both oral and written communications 
  • Demonstrate sound knowledge, flexibility, creativity and proactivity as well as practice adaptive change management and engagement in order to guarantee clinical operational excellence and continuous improvement
  • Proven Project Management skills in a matrix environment 
  • Able to work proactive by anticipating potential issues with a clinical trial. 
  • Show empathy, respect and fairness
  • Live a culture of cooperation and team-work and take action to prevent and solve conflicts
  • Ability to work independently and as part of a team
  • Work proactively and encouraging others, show assertiveness
  • Strong communication, negotiation, decision making and presentation skills
  • Effective project planning, conduct and supervision abilities 
  • Analytical and systematic thinking, proactive problem identification, solution orientated, ability to drive project and clinical requirements

Your contact person

Tilman Grumbd
Geschäftsführer

Address

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