Senior Project Manager for Clinical and Non Interventional Research (m/w/divers) 

Kantar Health GmbH, Munich

Kantar Health have a vacancy for a Senior Project Manager in our fast-growing Clinical & Real World Research Team in Munich. As a Senior Project Manager, you’ll engage with multiple senior level clients to understand their needs and work with internal stakeholders to leverage Kantar Health global assets to respond to those needs.

Kantar Health is a leading global healthcare consulting company and trusted advisor to many of the world’s leading pharmaceutical, biotech, and medical device and diagnostic companies. It combines evidence-based research capabilities with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and brand and marketing expertise to help clients evaluate opportunities, launch products and maintain brand and market leadership. Kantar Health CRO business has over 35 years of experience in the field of Clinical trials, Late Phase studies, non interventional studies and epidemiological research.
 

KEY OUTCOMES
  • Overtake the main responsibility for study set-up, administration, maintenance and co-ordination of clinical trials and/or NIS and for the allocation of resources according to study requirements.
  • Ensure that the conduct of clinical trials and/or non-interventional study (NIS) is in compliance with the currently approved protocol/amendment(s), GCP/GPP guidelines, relevant SOPs and all applicable regulatory requirements.
  • For sensitive issues (e.g. financial issues, escalation plan) the Senior Clinical Project Manager acts as a pivotal point of contact for the Kantar Health study team, the investigative sites as well as for Sponsors and possible further external suppliers (e.g. central lab, translation services).
  • Participation in proposal and budget preparation and in preparation of client presentation (e.g. bid defense meeting)
  • Responsible for the supervision and management of the study budget, including review of invoices (project fees/investigator fees) and forward invoices to the Sponsor
  • Lead the coordination of activities related to data management, safety, statistic and medical writing within his/her own projects
  • Set-up of clear communication lines between the study team members (national and international)
  • Set-up and maintenance of study timelines and project specific working instructions
  • Act as central contact between study team (in Germany and at Kantar affiliates), investigative  site, Sponsor and – as applicable – external suppliers
  • Responsible for the creation of study documents (e.g. study protocol/observation plan, CRF)
  • Overtake the main responsibility for a successful management of the submission and notification process in the countries participating in each study
  • Set up and attendance of project meetings


CAPABILITIES
 
  • Bachelor degree in Life Sciences, Nursing Licensure, Pharmacy or Public Health.  An epidemiological background will be highly recognized
  • Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods
  • A minimum of 5 years of clinical project management experience, with main focus in late phase studies/post launch studies with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required
  • Deep experience and knowledge in late phase/non interventional research and all the regulatory requirements related to the setting of this type of studies in the European countries
  • Specialized adviser in late phase and non-interventional business for internal stakeholders or external clients
  • Great communicator for transferring proactively knowledge and guide understanding of research standards and principles
  • Excellent organizational and communication skills
  • Open minded for innovation, new approaches and for creating solutions across different type of business in the research arena
  • Experience handling with clients scientific discussions as well as financial issues
  • Complete grasp of complex interrelations
  • Careful, precise work
  • Team player and cross-sectional competence
  • Very good knowledge of MS Office
  • Read, write and speak fluent English and German; excellent verbal and written communication skills. 


JOIN US
 
We want for our employees to feel appreciated. Therefore, we take the personal development very seriously. We value a positive working environment with flexible working hours, specific training measures as well as a variety of additional social benefits. Exciting topics, committed teams and friendly colleagues – ideal conditions for your personal development. Let us convince you.
 
 
We look forward to receiving your application indicating your salary expectation and period of notice. Please notice that we accept applications exclusively via our online form.

 

HR CONTACT
Mrs Zuzana Markušková
Tel. +420 778 473 164
www.kantardeutschland.de

Kantar legt Wert auf Vielfalt und Chancengleichheit.
Kantar aims for diversity and equal opportunities.