A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.
To support our department Clinical Development & Drug Safety, we are looking for a Senior Clinical Project Leader (all genders) for an open ended full-time position, starting at the earliest date possible.
The Senior Clinical Project Leader is responsible and accountable 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.
The Senior Clinical Project Leader is 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. The Senior Clinical Project Leader works in cross-functional teams and drives oversight of CRO’s and vendor management, has in-depth knowledge of clinical operations and strategic understanding and experience of how cross-functional teams jointly achieve objective, utilizing knowledge of the organization, processes, customers and key business drivers to increase effectiveness.
The Clinical Project Leader prepares status reports and is 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) and Preparation of study-relevant information for authorities and ethics committees and investigator meetings.
Who you are:
- Advanced degree (MD, PhD) in Life Sciences (Human Medicine preferred, Biology, Chemistry,Pharmacists) or equivalent , work experience that provides knowledge of theories, principles and concepts within the relevant medicine preferably in Immunology, Allergy, ENT, Dermatology, Pulmonology or Pediatrics.
- Requires substantial professional experience (8 – 10 years) in clinical research in Pharmaceutical or Biotechnology Industry or within clinical CROs with at least 8-10 years of expertise in clinical trial management including management responsibility
- Proven experience in all aspects of 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
- Collegial teamwork and flexibility
- Excellent communication skills in German and English language
- Willingness to travel
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