Biologist, Chemist as Clinical Project Manager - Immunology, Allergy (
Posted on Apr 16, 2019 by Merck KGaA
A career at Merck is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
We are a dynamic growing, international pharmaceutical company headquartered in Reinbek near Hamburg. Within the global Merck KGaA, Darmstadt, Germany pharmaceutical, chemistry and life science group, we have with great success specialized in the development, manufacture and sale of preparations to diagnose and treat allergic diseases. We are amongst the leading pharmaceutical companies in the area of specific immunotherapy. Your role: This position is responsible for clinical project planning, organization, implementation, tracking and evaluation of global clinical trials (phase I - IV) according to ICH and GCP standards, other applicable regulations and internal SOPs. This includes also the coordination, cooperation and supervision of trial-related activities within Allergopharma and clinical CROs and with further service providers in the field of clinical trials.
This role is also accountable to drive and monitor protocol related activities throughout the lifecycle of the study ensuring targets are met according to timelines, budget and quality expectations. You work in cross-functional teams and drives oversight of CRO's and vendor management. Furthermore, you prepare status reports and are responsible for all activities related to clinical trial management, from planning through organization to successful completion. This includes preparation of study outlines, study protocols, investigator information meetings and clinical trial reports, CRFs, Ensuring the correct creation and archiving the Trial Master File (TMF) as well as preparation of study-relevant information for authorities, ethics committees and investigator meetings. Who you are: Advanced degree (MD, PhD) in Life Sciences (Human Medicine, Biology, Chemistry, Pharmacists) or equivalent
Advanced work experience of theories, principles and concepts within the relevant medicine preferably in Immunology, Allergy, ENT, Dermatology, Pulmonology or Pediatrics
Relevant professional experience in clinical research in Pharmaceutical or Biotechnology Industry or within clinical CROs with several years of expertise in clinical trial management including management responsibility
Proven experience in clinical trial management including vendor management and budget responsibility
Proven track record of managing global clinical trials
Very good MS Office and Project Management Skills
Excellent communication skills in German and English language
What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!