Global Clinical Trial Manager

Open for hire at one of the following locations –  Mainz iNeST Facility, Cambridge Erie Street. - Job ID: 7188 

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 Manager 

The Clinical Trial Manager (CTM) is responsible for supporting the Sr. Global Clinical Trial Manager and/or Associate Director, Global Clinical Trial Leader with the execution of a clinical trial(s) or leading the execution of smaller trials, mainly with regard to operational and administrative aspects. This implies being involved in 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 such as supporting the cross-functional operational project team lead, independent supervision/ control of some third-party providers, ensuring the timely performance of assigned responsibilities, as well as problem and issue resolution by interacting with other departments as necessary.

Responsibilities:

• Schedules and coordinates meetings, prepares and reviews agendas, presentation materials and minutes for study team meetings or other meetings as delegated. Study dependent meeting facilitation may be required
• Support in preparation of regular status reports to ADCO/SDCO, VP and Chief Medical Officer (CMO), including presentation of project status in meetings.
• Overlooking the clinical operation trial budget.
• Proactive communication with PM and ADCO in case of expected variances to the project plan including timelines, quality, and budget issues.
• Oversight of project timelines and deliverables.
• May be involved in Set-up or oversight of study related documents such as 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 some project activities with other internal departments or external vendors from start-up to close out of a clinical trial.
• Instruction and supervision of GCTS (in the scope of a project).
• Escalation to team lead in case of problems within the clinical trial
• Oversight and support in planning and conduct of project training prior to starting project activities

Requirements:

• A Bachelor’s degree in the life sciences is required or a degree in a related field with experience in a medical profession such as Nurse, Medical Technical Assistant, or Pharmaceutical Technical Assistant
• Minimum 4 years of experience in pharmaceutical/biotech or related industry in project management, regulatory submissions, monitoring of clinical trials as a lead, with some experience coordinating global study activities. An advanced degree in a related field with a minimum of three (3) years of relevant work experience may be considered.
• Global Phase I-III experience preferred
• Experience using standard software (Word, Excel, Power Point, MS Project and familiarity with different technical solutions such as eTMF, IWRS, EDC, etc. 
• Some knowledge and experience working with legislation and international guidelines (ICH-GCP) for the performance of clinical research projects.
• Familiarity with Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring.
• 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 – Mainz iNeST Facility, 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!