Senior Clinical Project Manager (m/w/d)

Ort: München, Bayern, Deutschland
Gehalt: n.A.
Spezialisierungen: Life Sciences
Vertragsart: Festanstellung
Jetzt bewerben

Our costumer, a leading international healthcare company, specialised in the field of Clinical trials, Late Phase studies, non-interventional studies and epidemiological research, is seeking highly qualified candidates to fill the position for their department in Munich:

(Senior) Clinical Project Manager (m/w/d) - Non Interventional Studies

Main Responsibilities and Accountabilities

  • 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 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 the company's 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

Qualifications

  • 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 3 years of clinical project management experience, with main focus in late phase studies/post launch studies with increasing levels of responsibility, ideally within CRO industry. Experience in the pharmaceutical or biotechnology industry is mandatory
  • 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 advisor in late phase and non-interventional business for internal stakeholders / external clients
  • Great communicator for proactively transferring 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
  • Excellent verbal and written communication skills in English and German

Benefits

  • 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

Your point of contact for this position is Ms. Margot Huber.

T: +49 (0) 176 / 557 39 180
E: m.huber(at)progressive.de

Jetzt bewerben