Global Clinical Trial Manager, Oncology

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Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
 

 

Global Clinical Trial Manager, Oncology

 

Responsibilities

 

The Clinical Trial Manager (CTM) is responsible for supporting the Sr. GCTM and/or ADGCTL 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.

 

•           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 before starting project activities.

 

 

Qualifications

 

Education

• Professional training/ academic degree:  A Bachelor’s degree in the life sciences or a degree in a related field with experience in a medical profession such as nurse, medical technical assistant, or pharmaceutical technical assistant is required.

 

Experience

• Some knowledge and experience working with legislation and international guidelines (ICH-GCP) for the performance of clinical research projects.
• Minimum four years of experience in pharmaceutical/biotech or related industry in project management, regulatory submissions, and monitoring of clinical trials as a lead, with some experience coordinating global study activities. An advanced degree in a related field with at least three (3) years of relevant work experience may be considered.
• Global Phase I-III experience preferred.

 

Special skills:

• Good communication skills, both written and spoken.
• Some experience presenting to cross-functional groups.
• Standard use of  Project Ma