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

Kantar Munich


Nobody knows consumers better than Kantar. Kantar is one of the world’s leading data, insight and consultancy companies. Working together across the whole spectrum of research and consulting disciplines, its specialist divisions, employing 30,000 people, provide inspirational insights and business strategies for clients in 100 countries. Kantar services are employed by over half of the Fortune Top 500 companies.

ROLE MISSION

Self-driven, detail-oriented and enthusiastic about an exciting challenge in the Clinical & Real World Research industry, you will find here the perfect role for yourself! As a Project Manager, you will work interdisciplinary and with international teams, and manage project management tasks to ensure quality and timely delivery of services.
 
Our Health Division 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. Our Health division has about 40 years of experience in the field of clinical trials, late phase studies, non-interventional studies and epidemiological research.
 
We deliver over 40 years of CRO experience, qualified expertise in clinical and non-interventional studies, global access to proprietary physician panels, innovative data collection services to the medical and healthcare research business worldwide, on the ground clinical services support in 80+ countries worldwide. We cover major markets including the Americas, Europe and Asia Pacific. Our European clinical team coordinates this network and manages globally all activities related to site selection, training, regulatory and legal affairs, quality management, data management, pharmacovigilance, statistics and medical writing services.
 
By joining our Health division, you will be joining a dynamic and innovative consulting company that capitalizes on ideas that may be conceived from sectors other than pharma and from broader marketing disciplines. Bring your expertise and innovation, be prepared to build your career on an international level!

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 CRO industry is required. Experience in the pharmaceutical, biotechnology or medical device industry could be beneficent
  • 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

WHAT WE OFFER
 
  • We support your work-life balance with flexible working hours
  • We give you room to breathe through our extraordinary number of vacation days (30 + 5)
  • We support your wish for a sabbatical
  • We value your work, e.g. by annual salary adjustments
  • We safeguard your well-being, for instance with an accident insurance and we offer a subsidized company pension scheme
  • We socialize in our cantina and coffee bar


We are looking forward to your application including your salary expecation and notice period. Please be aware that due to data privacy, we are only able to accept your application via our online form. 

HR CONTACT 
Sabine Reiter
Tel. +49 89 56001613
www.kantardeutschland.de


Kantar aims for diversity and equal opportunities.