Senior Clinical Trial Manager
Open for hire at one of the following locations – Cambridge Erie Street. - Job ID: 7110
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As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Senior Clinical Trial Manager
The Senior Clinical Trial Manager (CTM) 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 to the leading of an operational project team, the supervision/ control of third-party providers, the timely performance of all services, as well as problem management by interacting with all departments involved. Support in preparation of regular status reports to ADCO/SDCO and Chief Medical Officer (CMO), including presentation of project status in meetings.
- Overlooking the clinical operation trial budget
- Opportune contact with Program Management and the Associate Director, Clinical Operations 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
- The Clinical Trial Manager (CTM) 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 leading the operational project team, supervision/ control of third-party providers, the timely performance of all services, as well as problem management by interacting with all departments involved.
Qualifications
Education
- Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
Experience
- Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
- Minimum 5 years of experience in project management, regulatory submissions, monitoring of clinical trials or clinical trial coordination with practice in project planning and structuring
- Prior experience with cell and gene therapy projects preferred
Benefits for you
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.
Click here to find out more about what we do, the careers we offer ans also the benefits we provide.
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.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Cambridge Erie Street. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!