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Global Clinical Trial Specialist

Open for hire at one of the following locations –  Cambridge Erie Street, Mainz iNeST Facility. - Job ID: 7191 

 

Become a member of the BioNTech Family!

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.


 

Global Clinical Trial Specialist 

 

The Global Clinical Trial Specialist (GCTS) assists the Senior Global Clinical Trial Manager and/or Associate Director, Global Clinical Trial Manager in study execution of selected trials.  The individual may be assigned to support one or more studies across a portfolio.  Primary support is both operational and administrative, including the preparation and processing of national and international project documents and supporting processes under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs.  S/he performs activities related of a project in the timelines specified for the project, and may take on individual tasks, under supervision to the Sr/GCTM and/or ADGCTM.  

 

Responsibilities:

 

  • Schedules and coordinates meetings, prepares agendas. May draft presentation materials and minutes for study team meetings with oversight and supervision of the Sr/GCTM and/or ADGCTM.
  • Organization and documentation of clinical trial team meetings.
  • Coordination and tracking of project timelines according to the project plan.
  • Coordination of study related documents such as country and site feasibility questionnaires, the Study Management Plan, Study Monitoring Plan, etc.
  • Supports coordination and/or review of clinical trial documents (e.g., protocol synopsis, investigator’s brochure (IB), patient informed consent forms (ICF), etc.).
  • Supports the planning and conduct of project training prior to the initiation of project activities; oversight of training matrix; documents completion by team members.
  • Supports organization of investigator meetings.
  • Supports the review and management of clinical trial monitoring reports.
  • Adherence to the regulatory requirements, ICH GCP guidelines, and the respective procedures (i.e., policies, SOPs, instructions).
  • Supports the process of investigator site selection.

 

Requirements:

 

  • A High School Diploma is required, Bachelor’s degree is preferred.

  • An advanced degree in a related field with a minimum of one (1) years of relevant work experience may be considered.

  • Basic or entry level knowledge and experience of GCP for the performance of clinical research projects.

  • Demonstrates some use of Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills.

  • Familiar with standard software (Word, Excel, Power Point, email) and learning different technical solutions.

  • Resourceful and demonstrates problem-solving skills.


 

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 and 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, Mainz iNeST Facility. 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!

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