(Senior) Global Clinical Trial Manager*

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Introduction

Everyone can achieve great things at BioNTech! We develop revolutionary approaches in the fight against cancer and other diseases. BioNTech wants to become the world’s leading biotechnology company for individualized cancer medicine. Our dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer!

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 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.
 

Key Responsibilities

 
  • 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 PM and ADCO 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.
  • Co-ordination 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)

Qualifications

  • Minimum 3 years of experience in project management, regulatory submissions, monitoring of clinical trials or clinical trial coordination with practice in project planning and structuring
  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects

Benefits

Medical, Dental and Vision Insurance
Life, AD&D, STD and LTD Insurance
HSA & FSA Spending Accounts
Health & Wellness, including free onsite gym access
Adoption & Surrogacy Assistance
Vacation and Unlimited Sick Time
Holidays and Floating Holidays, including discretionary winter shutdown
401(K) Plan with Significant Company Match
Tuition Reimbursement and Professional Development
Commuting Assistance and free onsite parking
Discounted Home and Auto Insurance
Pet Insurance
And more!

To Apply, EEO and BioNTech Websites

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form. #LI-DCA

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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