Senior Project Manager (m/f/d)

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

Responsibilities

• 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 incompliance 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 Cerner Enviza study team, the participating 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 Cerner Enviza affiliates), 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 and for negotiation of contracts (sites, vendors etc.)
• Set up and attendance of project meetings
• Participation in process improvement procedures/SOPs updates
• Training and mentoring team members in collaboration with the Team Leader

Additional Information

Qualifications

• Master’s Degree (or similar qualification) in Life Sciences, Pharmacy or Public Health or relevant professional education with several years of practical experience. An epidemiological background will be highly recognized
• Several years of experience within a mid to large size complex multinational company focusing on clinical/non-interventional studies in the areas of medicinal products and medical devices. Preferably in a CRO(s)
• Deep knowledge of GCP, GEP, GPP
• Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods
• Broad knowledge of different therapeutic areas
• Open-minded for innovation, new approaches and for creating solutions across different type of business in the research arena
• Experience in preparing proposals and budgets as well as participation in bid meetings
• Strong experience handling with clients, scientific discussions as well as financial issues
• Excellent organizational and communication skills
• Great communicator for proactively transferring knowledge and guide understanding of research standards and principles
• Team player and cross-sectional competence
• Excellent verbal and written communication skills in English and German
• Careful, precise work
• Very good knowledge of MS Office