Manager Clinical Trial (m/w/d)
Mainz, Germany; London, United Kingdom | full time | Job ID: 8722
The Clinical Trial Manager is responsible for the execution of clinical trials, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. S/he performs activities related with the leading of an operational project team, the supervision/ control of third party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved.
Support in preparation of regular status reports to Platform and Portfolio leads, and Chief Medical Officer (CMO), including presentation of project status in meeting
Overlooking the clinical operation trial budget
Opportune contact with Project Manager and Platform lead in case of divergences from the project plan
Oversight on project timelines and deliverables
Set-up or oversight of study related documents such like Trial Management Plan, Monitor Manual, etc.
Contribution to and review of study core documents, e.g. synopsis, investigator’s brochure, patient informed consent documents etc.
Coordination of project activities with other internal departments or external vendors from start-up to close out of a clinical trial
Instruction and supervision of CTCs, CRAs and CTAs (in the scope of a project)
Point of contact in case of problems within the clinical trial
Support in planning and conduct of project training prior to starting project activities, oversight
Background in natural/life sciences or medicine (University degree or experience in a medical profession such as Nurse, Medical Technical Assistant, or Pharmaceutical Technical Assistant)
Minimum of 3 years of experience in project management, regulatory submissions, monitoring of clinical trials, or clinical trial coordination
Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
Very good English (written and spoken)
Experience in usual software (Word, Excel, Power Point, MS Projects)
Able to recognize problems and provide solutions
Good organizational and communicative skills
Pro-active way of working & ready to take over responsibility
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.